87
1 List 01 SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:……………………….. NO SRNO SPEC_CONCAT UNIT OF MEASURE COMP_REG ITEM_LEVEL VEN RECOMMENDATION OF SUB COMM ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile. NOS C 4 N continue 2 13515301 ASD Occlusion Device, Amplatzer type or similar, size 5mm, sterile. NOS C 4 N continue 3 13515302 ASD Occlusion Device, Amplatzer type or similar, size 6mm, sterile. NOS C 4 N continue 4 13515303 ASD Occlusion Device, Amplatzer type or similar, size 7mm, sterile. NOS C 4 N continue 5 13515304 ASD Occlusion Device, Amplatzer type or similar, size 8mm, sterile. NOS C 4 N continue 6 13515305 ASD Occlusion Device, Amplatzer type or similar, size 9mm, sterile. NOS C 4 N continue 7 13515306 ASD Occlusion Device, Amplatzer type or similar, size 10mm, sterile. NOS C 4 N continue 8 13515307 ASD Occlusion Device, Amplatzer type or similar, size 11mm, sterile. NOS C 4 N continue 9 13515308 ASD Occlusion Device, Amplatzer type or similar, size 12mm, sterile. NOS C 4 E continue 10 13515309 ASD Occlusion Device, Amplatzer type or similar, size 13mm, sterile. NOS C 4 E continue 11 13515310 ASD Occlusion Device, Amplatzer type or similar, size 14mm, sterile. NOS C 4 E continue 12 13515311 ASD Occlusion Device, Amplatzer type or similar, size 15mm, sterile. NOS C 4 E continue 13 13515312 ASD Occlusion Device, Amplatzer type or similar, size 16mm, sterile. NOS C 4 E continue 14 13515313 ASD Occlusion Device, Amplatzer type or similar, size 17mm, sterile. NOS C 4 E continue 15 13515314 ASD Occlusion Device, Amplatzer type or similar, size 18mm, sterile. NOS C 4 N continue 16 13515315 ASD Occlusion Device, Amplatzer type or similar, size 19mm, sterile. NOS C 4 E continue 17 13515316 ASD Occlusion Device, Amplatzer type or similar, size 20mm, sterile. NOS C 4 E continue 18 13515317 ASD Occlusion Device, Amplatzer type or similar, size 22mm, sterile. NOS C 4 N continue 19 13515318 ASD Occlusion Device, Amplatzer type or similar, size 24mm, sterile. NOS C 4 E continue 20 13515319 ASD Occlusion Device, Amplatzer type or similar, size 26mm, sterile. NOS C 4 E continue 21 13515320 ASD Occlusion Device, Amplatzer type or similar, size 28mm, sterile. NOS C 4 N continue 22 13515321 ASD Occlusion Device, Amplatzer type or similar, size 30mm, sterile. NOS C 4 E continue 23 13515322 ASD Occlusion Device, Amplatzer type or similar, size 32mm, sterile. NOS C 4 E continue

ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

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Page 1: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

1 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F

MEA

SUR

E

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

ASD/PDA/VSD OCCLUSION DEVICES

ASD OCCLUSION DEVICES

1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile.

NOS C 4 N continue

2 13515301 ASD Occlusion Device, Amplatzer type or similar, size 5mm, sterile.

NOS C 4 N continue

3 13515302 ASD Occlusion Device, Amplatzer type or similar, size 6mm, sterile.

NOS C 4 N continue

4 13515303 ASD Occlusion Device, Amplatzer type or similar, size 7mm, sterile.

NOS C 4 N continue

5 13515304 ASD Occlusion Device, Amplatzer type or similar, size 8mm, sterile.

NOS C 4 N continue

6 13515305 ASD Occlusion Device, Amplatzer type or similar, size 9mm, sterile.

NOS C 4 N continue

7 13515306 ASD Occlusion Device, Amplatzer type or similar, size 10mm, sterile.

NOS C 4 N continue

8 13515307 ASD Occlusion Device, Amplatzer type or similar, size 11mm, sterile.

NOS C 4 N continue

9 13515308 ASD Occlusion Device, Amplatzer type or similar, size 12mm, sterile.

NOS C 4 E continue

10 13515309 ASD Occlusion Device, Amplatzer type or similar, size 13mm, sterile.

NOS C 4 E continue

11 13515310 ASD Occlusion Device, Amplatzer type or similar, size 14mm, sterile.

NOS C 4 E continue

12 13515311 ASD Occlusion Device, Amplatzer type or similar, size 15mm, sterile.

NOS C 4 E continue

13 13515312 ASD Occlusion Device, Amplatzer type or similar, size 16mm, sterile.

NOS C 4 E continue

14 13515313 ASD Occlusion Device, Amplatzer type or similar, size 17mm, sterile.

NOS C 4 E continue

15 13515314 ASD Occlusion Device, Amplatzer type or similar, size 18mm, sterile.

NOS C 4 N continue

16 13515315 ASD Occlusion Device, Amplatzer type or similar, size 19mm, sterile.

NOS C 4 E continue

17 13515316 ASD Occlusion Device, Amplatzer type or similar, size 20mm, sterile.

NOS C 4 E continue

18 13515317 ASD Occlusion Device, Amplatzer type or similar, size 22mm, sterile.

NOS C 4 N continue

19 13515318 ASD Occlusion Device, Amplatzer type or similar, size 24mm, sterile.

NOS C 4 E continue

20 13515319 ASD Occlusion Device, Amplatzer type or similar, size 26mm, sterile.

NOS C 4 E continue

21 13515320 ASD Occlusion Device, Amplatzer type or similar, size 28mm, sterile.

NOS C 4 N continue

22 13515321 ASD Occlusion Device, Amplatzer type or similar, size 30mm, sterile.

NOS C 4 E continue

23 13515322 ASD Occlusion Device, Amplatzer type or similar, size 32mm, sterile.

NOS C 4 E continue

Page 2: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

2 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

24 13515323 ASD Occlusion Device, Amplatzer type or similar, size 34mm, sterile.

NOS C 4 E continue

25 13515324 ASD Occlusion Device, Amplatzer type or similar, size 36mm, sterile.

NOS C 4 E continue

26 13515325 ASD Occlusion Device, Amplatzer type or similar, size 38mm, sterile.

NOS C 4 E continue

27 13515326 ASD Occlusion Device, Amplatzer type or similar, size 40mm, sterile.

NOS C 4 N continue

28 13515400 ASD Occlusion Device, Multifenestrated type or similar, size 18mm, sterile.

NOS C 4 N continue

29 13515401 ASD Occlusion Device, Multifenestrated type or similar, size 25mm, sterile.

NOS C 4 N continue

30 13515402 ASD Occlusion Device, Multifenestrated type or similar, size 30mm, sterile.

NOS C 4 N continue

31 13515403 ASD Occlusion Device, Multifenestrated type or similar, size 35mm, sterile.

NOS C 4 N continue

32 13515404 ASD Occlusion Device, Multifenestrated type or similar, size 40mm, sterile.

NOS C 4 N continue

33 13515500 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 18mm, sterile.

NOS C 4 N continue

34 13515501 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 25mm, sterile.

NOS C 4 N continue

35 13515502 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 30mm, sterile.

NOS C 4 N continue

36 13515503 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 35mm, sterile.

NOS C 4 N continue

37 13515503 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 35mm, sterile.

NOS C 4 N continue

PDA OCCLUSION DEVICES

38 13515700 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 3mm x 4mm, sterile.

NOS C 4 N continue

39 13515701 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 3mm x 6mm, sterile.

NOS C 4 N continue

40 13515702 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 4mm x 4mm, sterile.

NOS C 4 N continue

41 13515703 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 4mm x 6mm, sterile.

NOS C 4 N continue

42 13515704 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 5mm x 4mm, sterile.

NOS C 4 N continue

43 13515705 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 5mm x 6mm, sterile.

NOS C 4 N continue

44 13515706 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 6mm x 4mm, sterile.

NOS C 4 N continue

45 13515707 PDA Occlusion Device, Amplatzer Duct Occluder II type or similar, size 6mm x6mm, sterile.

NOS C 4 N continue

Page 3: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

3 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

46 13515600 PDA Occlusion Device, Amplatzer type or similar, size 5mm x 4mm, sterile.

NOS C 4 N continue

47 13515601 PDA Occlusion Device, Amplatzer type or similar, size 6mm x 4mm, sterile.

NOS C 4 N continue

48 13515602 PDA Occlusion Device, Amplatzer type or similar, size 8mm x 6mm, sterile.

NOS C 4 N continue

49 13515603 PDA Occlusion Device, Amplatzer type or similar, size 10mm x 8mm, sterile.

NOS C 4 N continue

50 13515604 PDA Occlusion Device, Amplatzer type or similar, size 12mm x 10mm, sterile.

NOS C 4 N continue

51 13515605 PDA Occlusion Device, Amplatzer type or similar, size 14mm x 12mm, sterile.

NOS C 4 N continue

52 13515606 PDA Occlusion Device, Amplatzer type or similar, size 16mm x 14mm, sterile.

NOS C 4 N continue

VSD OCCLUSION DEVICES

53 13515800 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 4mm, sterile .

NOS C 4 N continue

54 13515801 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 6mm, sterile .

NOS C 4 N continue

55 13515802 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 8mm, sterile .

NOS C 4 N continue

56 13515803 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 9mm, sterile .

NOS C 4 N continue

57 13515804 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 10mm, sterile.

NOS C 4 N continue

58 13515805 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 11mm, sterile.

NOS C 4 N continue

59 13515806 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 12mm, sterile.

NOS C 4 N continue

60 13515807 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 13mm, sterile.

NOS C 4 N continue

61 13515808 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 14mm, sterile.

NOS C 4 N continue

62 13515809 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 15mm, sterile.

NOS C 4 N continue

63 13515810 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 16mm, sterile.

NOS C 4 N continue

64 13515811 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 17mm, sterile.

NOS C 4 N continue

65 13515812 VSD Occlusion Device, perimembrane, Amplatzer type or similar, size 18mm, sterile.

NOS C 4 N continue

Page 4: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

4 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

66 13515900 VSD Occlusion Device, muscular, Amplatzer type or similar, size 4mm, sterile.

NOS C 4 N continue

67 13515901 VSD Occlusion Device, muscular, Amplatzer type or similar, size 6mm, sterile.

NOS C 4 N continue

68 13515902 VSD Occlusion Device, muscular, Amplatzer type or similar, size 8mm, sterile.

NOS C 4 N continue

69 13515903 VSD Occlusion Device, muscular, Amplatzer type or similar, size 10mm, sterile.

NOS C 4 N continue

70 13515904 VSD Occlusion Device, muscular, Amplatzer type or similar, size 12mm, sterile.

NOS C 4 N continue

71 13515905 VSD Occlusion Device, muscular, Amplatzer type or similar, size 14mm, sterile.

NOS C 4 N continue

72 13515906 VSD Occlusion Device, muscular, Amplatzer type or similar, size 16mm, sterile.

NOS C 4 N continue

73 13515907 VSD Occlusion Device, muscular, Amplatzer type or similar, size 18mm, sterile.

NOS C 4 N continue

74 13516000 VSD Occlusion Device, post - infarction muscular, Amplatzer type or similar, size 16mm, sterile.

NOS C 4 N continue

75 13516001 VSD Occlusion Device, post - infarction muscular, Amplatzer type or similar, size 18mm, sterile.

NOS C 4 N continue

76 13516002 VSD Occlusion Device, post - infarction muscular, Amplatzer type or similar, size 20mm, sterile.

NOS C 4 N continue

77 13516003 VSD Occlusion Device, post - infarction muscular, Amplatzer type or similar, size 22mm, sterile.

NOS C 4 N continue

78 13516004 VSD Occlusion Device, post - infarction muscular, Amplatzer type or similar, size 24mm, sterile.

NOS C 4 N continue

EMBOLISATION COILS

79 13516100 Embolisation Coil, Cooks type, MRI compatible, 0.97mm (0.038") diameter, size 3mm x 5cm, sterile.

NOS C 4 N specs amended

80 13516101 Embolisation Coil, Cooks type, MRI compatible, 0.97mm (0.038") diameter, size 5mm x 5cm, sterile.

NOS C 4 N specs amended

81 13516102 Embolisation Coil, Cooks type, MRI compatible, 0.97mm (0.038") diameter, size 5mm x 8cm, sterile.

NOS C 4 N specs amended

82 13516103 Embolisation Coil, Cooks type, MRI compatible, 0.97mm (0.038") diameter, size 6mm x 8cm, sterile.

NOS C 4 N specs amended

83 13516200 Embolisation Coil, Cooks type, MRI compatible, 1.32mm (0.052") diameter, size 6mm x 8cm, sterile.

NOS C 4 N specs amended & re-introduced

84 13516300 Embolisation Coil, detachable, 0.89mm (0.035") diameter, Cooks type, MRI compatible, size 3mm x 5cm, sterile.

NOS C 4 N specs amended

85 13516301 Embolisation Coil, detachable, 0.89mm (0.035") diameter, Cooks type, MRI compatible, size 5mm x 6cm, sterile.

NOS C 4 N specs amended

Page 5: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

5 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

86 13516302 Embolisation Coil, detachable, 0.89mm (0.035") diameter, Cooks type, MRI compatible, size 5mm x 8cm, sterile.

NOS C 4 N specs amended

87 13516303 Embolisation Coil, detachable, 0.89mm (0.035") diameter, Cooks type, MRI compatible, size 6.5mm x 8cm, sterile.

NOS C 4 N specs amended

88 NEW

13516201 Embolisation Coil, Nester type, 0.46mm (0.018") diameter, size 3mm x 14cm, sterile.

NOS C 4 N added NEW as essential

89 NEW

13516202 Embolisation Coil, Nester type, 0.46mm (0.018") diameter, size 4mm x 14cm, sterile.

NOS C 4 N added NEW as essential

90 NEW

13516203 Embolisation Coil, Nester type, 0.46mm (0.018") diameter, size 6mm x 14cm, sterile.

NOS C 4 N added NEW as essential

91 NEW

13516204 Embolisation Coil, Nester type, 0.46mm (0.018") diameter, size 8mm x 14cm, sterile.

NOS C 4 N added NEW as essential

92 NEW

13516205 Embolisation Coil, Nester type, 0.46mm (0.018") diameter, size 10mm x 14cm, sterile.

NOS C 4 N added NEW as essential

93 NEW

13516206 Embolisation Coil, Nester type, 0.89mm (0.035") diameter, size 4mm x 14cm, sterile.

NOS C 4 N added NEW as essential

94 NEW

13516207 Embolisation Coil, Nester type, 0.89mm (0.035") diameter, size 6mm x 14cm, sterile.

NOS C 4 N added NEW as essential

95 NEW

13516208 Embolisation Coil, Nester type, 0.89mm (0.035") diameter, size 8mm x 14cm, sterile.

NOS C 4 N added NEW as essential

96 NEW

13516209 Embolisation Coil, Nester type, 0.89mm (0.035") diameter, size 10mm x 14cm, sterile.

NOS C 4 N added NEW as essential

97 NEW

13516210 Embolisation Coil, Nester type, 0.89mm (0.035") diameter, size 12mm x 14cm, sterile.

NOS C 4 N added NEW as essential

98 NEW

13516211 Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 3-2mm x 2cm, sterile.

NOS C 4 N added NEW as essential

99 NEW

13516212 Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 4-2mm x 4cm, sterile.

NOS C 4 N added NEW as essential

100 NEW

13516213 Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 5-2mm x 5cm, sterile.

NOS C 4 N added NEW as essential

101 NEW

13516214 Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 6-2mm x 7cm, sterile.

NOS C 4 N added NEW as essential

102 NEW

13516215 Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 8-4mm x 9cm, sterile.

NOS C 4 N added NEW as essential

103 NEW

13516216

Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 7-3mm x 9.5cm, sterile.

NOS C 4 N added NEW as essential

104 NEW

13516217

Embolisation Coil, Tornado type, 0.46mm (0.018") diameter, size 10-4mm x 14.2cm, sterile.

NOS C 4 N added NEW as essential

105 NEW

13516218

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 4-3mm x 2.6cm, sterile.

NOS C 4 N added NEW as essential

106 NEW

13516219

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 5-3mm x 4.1cm, sterile.

NOS C 4 N added NEW as essential

107 NEW

13516220

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 6-3mm x 5.8cm, sterile.

NOS C 4 N added NEW as essential

108 NEW

13516221 Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 7-3mm x 8cm, sterile.

NOS C 4 N added NEW as essential

Page 6: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

6 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

109 NEW

13516222 Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 8-4mm x 8cm, sterile.

NOS C 4 N added NEW as essential

110 NEW

13516223

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 8-5mm x 8.2cm, sterile.

NOS C 4 N added NEW as essential

111 NEW

13516224

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 10-4mm x 12.5cm, sterile.

NOS C 4 N added NEW as essential

112 NEW

13516225

Embolisation Coil, Tornado type, 0.89mm (0.035") diameter, size 10-5mm x 12.5cm, sterile.

NOS C 4 N added NEW as essential

VASCULAR PLUG

113 NEW

13515201

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 4mm x 7mm, sterile.

NOS C 4 N added NEW as essential

114 NEW

13515202

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 6mm x 7mm, sterile.

NOS C 4 N added NEW as essential

115 NEW

13515203

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 8mm x 7mm, sterile.

NOS C 4 N added NEW as essential

116 NEW

13515204

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 10mm x 7mm, sterile.

NOS C 4 N added NEW as essential

117 NEW

13515205

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 12mm x 8mm, sterile.

NOS C 4 N added NEW as essential

118 NEW

13515206

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 14mm x 8mm, sterile.

NOS C 4 N added NEW as essential

119 NEW

13515207

Vascular Plug, Amplatzer vascular plug type I, compatible with 4F - 6F sheaths or 5F - 8F guide catheters, size 16mm x 8mm, sterile.

NOS C 4 N added NEW as essential

120 NEW

13515208

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 3mm x 6mm, sterile.

NOS C 4 N added NEW as essential

121 NEW

13515209

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 4mm x 6mm, sterile.

NOS C 4 N added NEW as essential

122 NEW

13515210

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 6mm x 6mm, sterile.

NOS C 4 N added NEW as essential

123 NEW

13515211

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 8mm x 7mm, sterile.

NOS C 4 N added NEW as essential

124 NEW

13515212

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 10mm x 7mm, sterile.

NOS C 4 N added NEW as essential

125 NEW

13515213

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 12mm x 9mm, sterile.

NOS C 4 N added NEW as essential

126 NEW

13515214

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 14mm x 10mm, sterile.

NOS C 4 N added NEW as essential

Page 7: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

7 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

127 NEW

13515215

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 16mm x 12mm, sterile.

NOS C 4 N added NEW as essential

128 NEW

13515216

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 18mm x 14mm, sterile.

NOS C 4 N added NEW as essential

129 NEW

13515217

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 20mm x 16mm, sterile.

NOS C 4 N added NEW as essential

130 NEW

13515218

Vascular Plug, Amplatzer vascular plug type II, compatible with 4F sheaths or 5F guide catheters, size 22mm x 18mm, sterile.

NOS C 4 N added NEW as essential

131 NEW

13515219

Vascular Plug, Amplatzer vascular plug type 4, compatible with 0.97mm (0.038") diameter diagnostic catheter, size 4mm x 10mm, sterile.

NOS C 4 N added NEW as essential

132 NEW

13515220

Vascular Plug, Amplatzer vascular plug type 4, compatible with 0.97mm (0.038") diameter diagnostic catheter, size 5mm x 10.5mm, sterile.

NOS C 4 N added NEW as essential

133 NEW

13515221

Vascular Plug, Amplatzer vascular plug type 4, compatible with 0.97mm (0.038") diameter diagnostic catheter, size 6mm x 11mm, sterile.

NOS C 4 N added NEW as essential,Deleted 13708500

134 NEW

13515222

Vascular Plug, Amplatzer vascular plug type 4, compatible with 0.97mm (0.038") diameter diagnostic catheter, size 7mm x 12.5mm, sterile.

NOS C 4 N added NEW as essential,Deleted 13708501

135 NEW

13515223

Vascular Plug, Amplatzer vascular plug type 4, compatible with 0.97mm (0.038") diameter diagnostic catheter, size 8mm x 13.5mm, sterile.

NOS C 4 N added NEW as essential,Deleted 13708502

136 13515500 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 18mm, sterile.

NOS C 4 N Continue

137 13515501 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 25mm, sterile.

NOS C 4 N Continue

138 13515502 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 30mm, sterile.

NOS C 4 N Continue

139 13515503 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 35mm, sterile.

NOS C 4 N Continue

140 13515503 ASD Occlusion Device, Patent Foramen Ovale (PFO), size 35mm, sterile.

NOS C 4 N Continue

Page 8: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

8 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

ANGIOGRAPHIC & GUIDING CATHETERS

ANGIOGRAPHIC CATHETERS

1 NEW

13507701

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

2 NEW

13507702

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

3 NEW

13507703

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

4 NEW

13507704

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

5 NEW

13507705

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

6 NEW

13507706

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

7 NEW

13507707

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

8 NEW

13507708

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

9 NEW

13507709

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 3, 100cm - 110cm length, sterile.

NOS 4 E Added NEW as essential

10 NEW

13507710

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

11 NEW

13507711

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

12 NEW

13507712

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

13 NEW

13507713

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

14 NEW

13507714

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

15 NEW

13507715

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 9: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

9 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

16 NEW

13507716

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

17 NEW

13507718

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

18 NEW

13507719

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

19 NEW

13507720

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

20 NEW

13507721

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

21 NEW

13508603

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

22 NEW

13508604

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

23 NEW

13508605

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

24 NEW

13508606

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

25 NEW

13508607

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

26 NEW

13508608

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

27 NEW

13508609

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

28 NEW

13508610

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

29 NEW

13508611

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

30 NEW

13507722

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

31 NEW

13507723

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

32 NEW

13507725

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

33 NEW

13507726

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

Page 10: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

10 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

34 NEW

13507728

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

35 NEW

13507729

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

36 NEW

13507730

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

37 NEW

13507731

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

38 NEW

13507733

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

39 NEW

13507734

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

40 NEW

13507735

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

41 NEW

13507736

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

42 NEW

13508612

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

43 NEW

13508613

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

44 NEW

13508614

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

45 NEW

13508615

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

46 NEW

13508616

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

47 NEW

13508617

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

48 NEW

13508618

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

49 NEW

13508619

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

50 NEW

13508620

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

51 NEW

13508621

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 11: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

11 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

52 NEW

13508622

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

53 NEW

13508623

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

54 13507601 Multipurpose Angiographic Catheter, with end hole only, size 4F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

55 13507801 Multipurpose Angiographic Catheter, with end hole and two side holes , size 4F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

56 13507901 Multipurpose Angiographic Catheter, with end hole only, size 4F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

57 13508101 Multipurpose Angiographic Catheter, with end hole and two side holes , size 4F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

58 13507602 Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

59 13507802 Multipurpose Angiographic Catheter, with end hole and two side holes , size 5F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

60 13507902 Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

61 13508102 Multipurpose Angiographic Catheter, with end hole and two side holes , size 5F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

62 13507603 Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

63 13507803 Multipurpose Angiographic Catheter, with end hole and two side holes , size 6F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

64 13507903 Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

65 13508103 Multipurpose Angiographic Catheter, with end hole and two side holes , size 6F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

66 NEW

13508104

Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

67 NEW

13508105

Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

68 NEW

13508106

Multipurpose Angiographic Catheter, with end hole only, size 7F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

69 NEW

13508107

Multipurpose Angiographic Catheter, with end hole only, size 8F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 12: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

12 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

70 13508700 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

71 13508800 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

72 13508900 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

73 13508701 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

74 13508801 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

75 13508901 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

76 13508702 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

77 13508802 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

78 13508902 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

79 13508201 Angiographic Catheter, pigtail, size 4F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

80 13507501 Angiographic Catheter, pigtail, size 4F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

81 13508302 Angiographic Catheter, pigtail, size 4F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

82 13508301 Angiographic Catheter, pigtail, size 4F, straight, 60cm - 80cm length, sterile.

NOS C 4 N continue

83 13508202 Angiographic Catheter, pigtail, size 5F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

84 13507502 Angiographic Catheter, pigtail, size 5F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 N continue

85 13508303 Angiographic Catheter, pigtail, size 5F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

86 13508203 Angiographic Catheter, pigtail, size 6F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

87 13507503 Angiographic Catheter, pigtail, size 6F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 N continue

88 13508304 Angiographic Catheter, pigtail, size 6F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

89 13509300 Angiographic Catheter, RIM type or similar, size 4F, 60cm - 80cm length, sterile. .

NOS C 4 N continue

90 13509301 Angiographic Catheter, RIM type or similar, size 5F, 60cm - 80cm length, sterile.

NOS C 4 N continue

91 NEW

13509401 Angiographic Catheter, Bypass Left, size 5F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

Page 13: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

13 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

92 NEW

13509402 Angiographic Catheter, Bypass Left, size 6F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

93 NEW

13509403 Angiographic Catheter, Bypass Left, size 7F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

94 NEW

13509404 Angiographic Catheter, Bypass Right, size 5F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

95 NEW

13509405 Angiographic Catheter, Bypass Right, size 6F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

96 NEW

13509406 Angiographic Catheter, Bypass Right, size 7F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

97 NEW

13509506 Angiographic Catheter, Ikari Curve Left, size 5F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

98 NEW

13509508 Angiographic Catheter, Ikari Curve Left, size 5F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

99 NEW

13509509 Angiographic Catheter, Ikari Curve Left, size 6F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

100 NEW

13509510 Angiographic Catheter, Ikari Curve Left, size 6F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

101 NEW

13509511 Angiographic Catheter, Ikari Curve Left, size 7F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

102 NEW

13509512 Angiographic Catheter, Ikari Curve Left, size 7F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

103 NEW

13509513

Angiographic Catheter, Ikari Curve Right, size 5F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

104 NEW

13509514

Angiographic Catheter, Ikari Curve Right, size 5F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

105 NEW

13509515

Angiographic Catheter, Ikari Curve Right, size 6F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

106 NEW

13509516

Angiographic Catheter, Ikari Curve Right, size 6F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

107 NEW

13509517

Angiographic Catheter, Ikari Curve Right, size 7F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

108 NEW

13509518

Angiographic Catheter, Ikari Curve Right, size 7F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

109 NEW

13509602

Angiographic Catheter, Internal Mammary Artery 1, size 5F, curve style IMA 1, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

110 NEW

13509603

Angiographic Catheter, Internal Mammary Artery 2, size 6F, curve style IMA 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

111 NEW

13509605

Angiographic Catheter, Internal Mammary Artery 3, size 7F, curve style IMA 3, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

112 NEW

13509606 Angiographic Catheter, TIG, size 5F, 110cm (approx.) length, sterile.

NOS C 4 N Added NEW as essential

113 NEW

13509607 Clot Extraction Catheter, hydrophilic, size 6F, 145cm (approx.) length, sterile.

NOS C 4 N Added NEW as essential

Page 14: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

14 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

114 13509000 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 4F, 60cm - 80cm length, sterile.

NOS C 4 E specs amended

115 13509200 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 5F, 60cm - 80cm length, sterile.

NOS C 4 E specs amended

116 13509001 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 5F, 100cm -110cm length, sterile.

NOS C 4 E specs amended

117 13509201 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 6F, 100cm -110cm length, sterile.

NOS C 4 E specs amended

118 13508400 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 4F, MP type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

119 13508401 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 5F, MP type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

120 13508500 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 4F, Yashiro type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

121 13508501 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 5F, Yashiro type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

122 13509700 Angiographic Catheter, multi-track type or similar, size 4F, 60cm (approx.) length, sterile.

NOS C 4 N continue

123 13509701 Angiographic Catheter, multi-track type or similar, size 4F, 80cm (approx.) length, sterile.

NOS C 4 N continue

124 13509702 Angiographic Catheter, multi-track type or similar, size 5F, 80cm (approx.) length, sterile.

NOS C 4 N continue

125 13509703 Angiographic Catheter, multi-track type or similar, size 5F, 100cm (approx.) length, sterile.

NOS C 4 N continue

126 13509704 Angiographic Catheter, multi-track type or similar, size 6F, 80cm (approx.) length, sterile.

NOS C 4 N continue

127 13509705 Angiographic Catheter, multi-track type or similar, size 6F, 100cm (approx.) length, sterile.

NOS C 4 N continue

128 13514000 Vessel Sizing Catheter, pigtail type, with two or more marker bands for measurement, size 4F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

129 13514002 Vessel Sizing Catheter, pigtail type, with two or more marker bands for measurement, size 5F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

130 13514001 Vessel Sizing Catheter, straight, with two or more marker bands for measurement, size 4F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

131 13514003 Vessel Sizing Catheter, straight, with two or more marker bands for measurement, size 5F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

132 13514101 Wedge Pressure Balloon Catheter, with two lumen, size 5F, 100cm - 110cm length, sterile.

NOS C 4 E continue

133 13514103 Wedge Pressure Balloon Catheter, with two lumen, size 6F, 100cm - 110cm length, sterile.

NOS C 4 E continue

134 13514102 Wedge Pressure Balloon Catheter, with two lumen, size 6F, 60cm - 80cm length, sterile.

NOS C 4 N continue

Page 15: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

15 List 01

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

135 13509100 Angiographic Catheter, Berman type or similar, size 4F, 60cm - 80cm length, sterile.

NOS C 4 N continue

136 13509101 Angiographic Catheter, Berman type or similar, size 5F, 60cm - 80cm length, sterile.

NOS C 4 N continue

137 13509102 Angiographic Catheter, Berman type or similar, size 6F, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

DELETED ITEMS

1 13514100 Wedge Pressure Balloon Catheter, with two lumen, size 4F, 100cm - 110cm length, sterile.

NOS C 4 E

2 13513301

Angiographic catheter for right coronary,Judkin type,usable length 100cm,size 4F,tip curve JR 3.0.Sterile.Packed individually and labelled accordingly.

NOS C 4 E

3 13508600 Angiographic Catheter, Sones type or similar, size 4F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

4 13508601 Angiographic Catheter, Sones type or similar, size 5F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

5 13508602 Angiographic Catheter, Sones type or similar, size 6F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

Page 16: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

16 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

ANGIOGRAPHIC & GUIDING CATHETERS

ANGIOGRAPHIC CATHETERS

1 NEW

13507701

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

2 NEW

13507702

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

3 NEW

13507703

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

4 NEW

13507704

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 4F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

5 NEW

13507705

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

6 NEW

13507706

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

7 NEW

13507707

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

8 NEW

13507708

Angiographic Catheter, Paediatric, Right Coronary, Judkin type or similar, size 5F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Added NEW as essential

9 NEW

13507709

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 3, 100cm - 110cm length, sterile.

NOS 4 E Added NEW as essential

10 NEW

13507710

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

11 NEW

13507711

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

12 NEW

13507712

Angiographic Catheter, Right Coronary, Judkin type or similar, size 4F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

13 NEW

13507713

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

14 NEW

13507714

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

15 NEW

13507715

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 17: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

17 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

16 NEW

13507716

Angiographic Catheter, Right Coronary, Judkin type or similar, size 5F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

17 NEW

13507718

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

18 NEW

13507719

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

19 NEW

13507720

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

20 NEW

13507721

Angiographic Catheter, Right Coronary, Judkin type or similar, size 6F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

21 NEW

13508603

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

22 NEW

13508604

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

23 NEW

13508605

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 4F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

24 NEW

13508606

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

25 NEW

13508607

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

26 NEW

13508608

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 5F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

27 NEW

13508609

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

28 NEW

13508610

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

29 NEW

13508611

Angiographic Catheter, Right Coronary, Amplazter type or similar, size 6F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

30 NEW

13507722

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

31 NEW

13507723

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

32 NEW

13507725

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

33 NEW

13507726

Angiographic Catheter, Left Coronary, Judkin type or similar, size 4F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

Page 18: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

18 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

34 NEW

13507728

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

35 NEW

13507729

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

36 NEW

13507730

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

37 NEW

13507731

Angiographic Catheter, Left Coronary, Judkin type or similar, size 5F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

38 NEW

13507733

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

39 NEW

13507734

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

40 NEW

13507735

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

41 NEW

13507736

Angiographic Catheter, Left Coronary, Judkin type or similar, size 6F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

42 NEW

13508612

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

43 NEW

13508613

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

44 NEW

13508614

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

45 NEW

13508615

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 4F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

46 NEW

13508616

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

47 NEW

13508617

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

48 NEW

13508618

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

49 NEW

13508619

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 5F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

50 NEW

13508620

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

51 NEW

13508621

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 19: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

19 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

52 NEW

13508622

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

53 NEW

13508623

Angiographic Catheter, Left Coronary, Amplazter type or similar, size 6F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Added NEW as essential

54 13507601 Multipurpose Angiographic Catheter, with end hole only, size 4F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

55 13507801 Multipurpose Angiographic Catheter, with end hole and two side holes , size 4F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

56 13507901 Multipurpose Angiographic Catheter, with end hole only, size 4F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

57 13508101 Multipurpose Angiographic Catheter, with end hole and two side holes , size 4F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

58 13507602 Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

59 13507802 Multipurpose Angiographic Catheter, with end hole and two side holes , size 5F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

60 13507902 Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

61 13508102 Multipurpose Angiographic Catheter, with end hole and two side holes , size 5F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

62 13507603 Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style A1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

63 13507803 Multipurpose Angiographic Catheter, with end hole and two side holes , size 6F, curve style A2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

64 13507903 Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style B1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

65 13508103 Multipurpose Angiographic Catheter, with end hole and two side holes , size 6F, curve style B2, 80cm - 100cm length, sterile.

NOS C 4 E specs amended

66 NEW

13508104

Multipurpose Angiographic Catheter, with end hole only, size 5F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

67 NEW

13508105

Multipurpose Angiographic Catheter, with end hole only, size 6F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

68 NEW

13508106

Multipurpose Angiographic Catheter, with end hole only, size 7F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

69 NEW

13508107

Multipurpose Angiographic Catheter, with end hole only, size 8F, curve style B1,100cm - 110cm length, sterile.

NOS C 4 E Added NEW as essential

Page 20: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

20 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

70 13508700 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

71 13508800 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

72 13508900 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 4F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

73 13508701 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

74 13508801 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

75 13508901 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 5F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

76 13508702 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 1, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

77 13508802 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 2, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

78 13508902 Angiographic Catheter, Sones type or similar, with end hole and 4 side ports, size 6F, curve style Son 3, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

79 13508201 Angiographic Catheter, pigtail, size 4F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

80 13507501 Angiographic Catheter, pigtail, size 4F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

81 13508302 Angiographic Catheter, pigtail, size 4F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

82 13508301 Angiographic Catheter, pigtail, size 4F, straight, 60cm - 80cm length, sterile.

NOS C 4 N continue

83 13508202 Angiographic Catheter, pigtail, size 5F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

84 13507502 Angiographic Catheter, pigtail, size 5F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 N continue

85 13508303 Angiographic Catheter, pigtail, size 5F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

86 13508203 Angiographic Catheter, pigtail, size 6F, angled 145 degrees, 100cm - 110cm length, sterile.

NOS C 4 E continue

87 13507503 Angiographic Catheter, pigtail, size 6F, angled 155 degrees, 100cm - 110cm length, sterile.

NOS C 4 N continue

88 13508304 Angiographic Catheter, pigtail, size 6F, straight, 100cm - 110cm length, sterile.

NOS C 4 N continue

89 13509300 Angiographic Catheter, RIM type or similar, size 4F, 60cm - 80cm length, sterile. .

NOS C 4 N continue

90 13509301 Angiographic Catheter, RIM type or similar, size 5F, 60cm - 80cm length, sterile.

NOS C 4 N continue

91 NEW

13509401 Angiographic Catheter, Bypass Left, size 5F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

Page 21: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

21 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

92 NEW

13509402 Angiographic Catheter, Bypass Left, size 6F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

93 NEW

13509403 Angiographic Catheter, Bypass Left, size 7F, curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

94 NEW

13509404 Angiographic Catheter, Bypass Right, size 5F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

95 NEW

13509405 Angiographic Catheter, Bypass Right, size 6F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 E Added NEW as essential

96 NEW

13509406 Angiographic Catheter, Bypass Right, size 7F, curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

97 NEW

13509506 Angiographic Catheter, Ikari Curve Left, size 5F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

98 NEW

13509508 Angiographic Catheter, Ikari Curve Left, size 5F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

99 NEW

13509509 Angiographic Catheter, Ikari Curve Left, size 6F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

100 NEW

13509510 Angiographic Catheter, Ikari Curve Left, size 6F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

101 NEW

13509511 Angiographic Catheter, Ikari Curve Left, size 7F, curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

102 NEW

13509512 Angiographic Catheter, Ikari Curve Left, size 7F, curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

103 NEW

13509513

Angiographic Catheter, Ikari Curve Right, size 5F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

104 NEW

13509514

Angiographic Catheter, Ikari Curve Right, size 5F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

105 NEW

13509515

Angiographic Catheter, Ikari Curve Right, size 6F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

106 NEW

13509516

Angiographic Catheter, Ikari Curve Right, size 6F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

107 NEW

13509517

Angiographic Catheter, Ikari Curve Right, size 7F, curve style IR 1.5, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

108 NEW

13509518

Angiographic Catheter, Ikari Curve Right, size 7F, curve style IR 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

109 NEW

13509602

Angiographic Catheter, Internal Mammary Artery 1, size 5F, curve style IMA 1, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

110 NEW

13509603

Angiographic Catheter, Internal Mammary Artery 2, size 6F, curve style IMA 2, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

111 NEW

13509605

Angiographic Catheter, Internal Mammary Artery 3, size 7F, curve style IMA 3, 90cm - 100cm length, sterile.

NOS C 4 N Added NEW as essential

112 NEW

13509606 Angiographic Catheter, TIG, size 5F, 110cm (approx.) length, sterile.

NOS C 4 N Added NEW as essential

113 NEW

13509607 Clot Extraction Catheter, hydrophilic, size 6F, 145cm (approx.) length, sterile.

NOS C 4 N Added NEW as essential

Page 22: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

22 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

114 13509000 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 4F, 60cm - 80cm length, sterile.

NOS C 4 E specs amended

115 13509200 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 5F, 60cm - 80cm length, sterile.

NOS C 4 E specs amended

116 13509001 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 5F, 100cm -110cm length, sterile.

NOS C 4 E specs amended

117 13509201 Angiographic Catheter, NIH type or similar, with 4 - 6 side holes, size 6F, 100cm -110cm length, sterile.

NOS C 4 E specs amended

118 13508400 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 4F, MP type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

119 13508401 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 5F, MP type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

120 13508500 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 4F, Yashiro type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

121 13508501 Angiographic Catheter, hydrophyllic coated tip, (Glide Catheter), size 5F, Yashiro type curve, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

122 13509700 Angiographic Catheter, multi-track type or similar, size 4F, 60cm (approx.) length, sterile.

NOS C 4 N continue

123 13509701 Angiographic Catheter, multi-track type or similar, size 4F, 80cm (approx.) length, sterile.

NOS C 4 N continue

124 13509702 Angiographic Catheter, multi-track type or similar, size 5F, 80cm (approx.) length, sterile.

NOS C 4 N continue

125 13509703 Angiographic Catheter, multi-track type or similar, size 5F, 100cm (approx.) length, sterile.

NOS C 4 N continue

126 13509704 Angiographic Catheter, multi-track type or similar, size 6F, 80cm (approx.) length, sterile.

NOS C 4 N continue

127 13509705 Angiographic Catheter, multi-track type or similar, size 6F, 100cm (approx.) length, sterile.

NOS C 4 N continue

128 13514000 Vessel Sizing Catheter, pigtail type, with two or more marker bands for measurement, size 4F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

129 13514002 Vessel Sizing Catheter, pigtail type, with two or more marker bands for measurement, size 5F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

130 13514001 Vessel Sizing Catheter, straight, with two or more marker bands for measurement, size 4F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

131 13514003 Vessel Sizing Catheter, straight, with two or more marker bands for measurement, size 5F, 100cm - 110cm length, sterile.

NOS C 4 N specs amended

132 13514101 Wedge Pressure Balloon Catheter, with two lumen, size 5F, 100cm - 110cm length, sterile.

NOS C 4 E continue

133 13514103 Wedge Pressure Balloon Catheter, with two lumen, size 6F, 100cm - 110cm length, sterile.

NOS C 4 E continue

134 13514102 Wedge Pressure Balloon Catheter, with two lumen, size 6F, 60cm - 80cm length, sterile.

NOS C 4 N continue

Page 23: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

23 List 02

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

135 13509100 Angiographic Catheter, Berman type or similar, size 4F, 60cm - 80cm length, sterile.

NOS C 4 N continue

136 13509101 Angiographic Catheter, Berman type or similar, size 5F, 60cm - 80cm length, sterile.

NOS C 4 N continue

137 13509102 Angiographic Catheter, Berman type or similar, size 6F, 80cm - 100cm length, sterile.

NOS C 4 N specs amended

DELETED ITEMS

1 13514100 Wedge Pressure Balloon Catheter, with two lumen, size 4F, 100cm - 110cm length, sterile.

NOS C 4 E

2 13513301

Angiographic catheter for right coronary,Judkin type,usable length 100cm,size 4F,tip curve JR 3.0.Sterile.Packed individually and labelled accordingly.

NOS C 4 E

3 13508600 Angiographic Catheter, Sones type or similar, size 4F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

4 13508601 Angiographic Catheter, Sones type or similar, size 5F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

5 13508602 Angiographic Catheter, Sones type or similar, size 6F, with end hole and 4 side ports, 100cm - 110cm length, sterile.

NOS C 4 N

Page 24: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

24 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

GUIDING CATHETERS

1 13509801 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, Inner diameter > 0.058", curve style AL 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

2 13509901 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, Inner diameter > 0.058", curve style AL 2, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

3 13510801 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, Inner diameter > 0.058", curve style AL 3, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

4 13509805 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, Inner diameter > 0.071", curve style AL 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

5 13509905 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, Inner diameter > 0.071", curve style AL 2, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

6 13510803 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, Inner diameter > 0.071", curve style AL 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

7 NEW

13510806

Coronary Guiding Catheter, Left, Amplazter type or similar, size 7F, Inner diameter > 0.081", curve style AL 1, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

8 NEW

13510807

Coronary Guiding Catheter, Left, Amplazter type or similar, size 7F, Inner diameter > 0.081", curve style AL 2, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

9 13510805 Coronary Guiding Catheter, Left, Amplazter type or similar, size 7F, Inner diameter > 0.081", curve style AL 3, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

10 13511001 Coronary Guiding Catheter, Right, Amplazter type or similar, size 5F, Inner diameter > 0.058", curve style AR 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

11 13511101 Coronary Guiding Catheter, Right, Amplazter type or similar, size 5F, Inner diameter > 0.058", curve style AR 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

12 13511003 Coronary Guiding Catheter, Right, Amplazter type or similar, size 6F, Inner diameter > 0.071", curve style AR 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

13 13511103 Coronary Guiding Catheter, Right, Amplazter type or similar, size 6F, Inner diameter > 0.071", curve style AR 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

14 13511005 Coronary Guiding Catheter, Right, Amplazter type or similar, size 7F, Inner diameter > 0.081", curve style AR 1, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

15 13511105 Coronary Guiding Catheter, Right, Amplazter type or similar, size 7F, Inner diameter > 0.081", curve style AR 2, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

Page 25: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

25 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

16 13512501 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JL 3.5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

17 13512602 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JL 4, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

18 13512700 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JL 4.5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

19 13512801 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JL 5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

20 13512502 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JL 3.5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

21 13512601 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JL 4, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

22 13512701 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JL 4.5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

23 13512802 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JL 5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

24 13512505 Coronary Guiding Catheter, Left, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JL 3.5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

25 13512604 Coronary Guiding Catheter, Left, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JL 4, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

26 13512702 Coronary Guiding Catheter, Left, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JL 4.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

27 13512805 Coronary Guiding Catheter, Left, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JL 5, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

28 13513401

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 3.5, 90cm - 100cm length,with side holes, sterile.

NOS C 4 E specs amended

29 13513501

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 4, 90cm - 100cm length,with side holes, sterile.

NOS C 4 E specs amended

30 13513600

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 4.5, 90cm - 100cm length,with side holes, sterile.

NOS C 4 N specs amended

31 13513701

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 5, 90cm - 100cm length, with side holes,sterile.

NOS C 4 E specs amended

Page 26: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

26 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

32 13513801

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 6, 90cm - 100cm length,with side holes, sterile.

NOS C 4 N specs amended

33 13513402

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 3.5, 90cm - 100cm length, with side hole,ssterile.

NOS C 4 E specs amended

34 13513502

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 4, 90cm - 100cm length, with side holes,sterile.

NOS C 4 E specs amended

35 13513601

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 4.5, 90cm - 100cm length, with side holes,sterile.

NOS C 4 E specs amended

36 13513702

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 5, 90cm - 100cm length,with side holes, sterile.

NOS C 4 E specs amended

37 13513802

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 6, 90cm - 100cm length,with side holes, sterile.

NOS C 4 N specs amended

38 13513405

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 3.5, 90cm - 100cm length, with side holes,sterile.

NOS C 4 E specs amended

39 13513505

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 4, 90cm - 100cm length, with side holes,sterile.

NOS C 4 E specs amended

40 13513602

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 4.5, 90cm - 100cm length,with side holes, sterile.

NOS C 4 N specs amended

41 13513705

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 5, 90cm - 100cm length,with side holes, sterile.

NOS C 4 E specs amended

42 13513805

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 6, 90cm - 100cm length,with side holes, sterile.

NOS C 4 N specs amended

43 NEW

13513806

Coronary Guiding Catheter, Right, Judkin type or similar, size 8F, Inner diameter > 0.081", curve style JR 4, 100cm - 110cm length, side holes,sterile.

NOS C 4 N added NEW as essential

44 NEW

13513807

Coronary Guiding Catheter, Right, Judkin type or similar, size 8F, Inner diameter > 0.081", curve style JR 4.5, 100cm - 110cm length,side holes, sterile.

NOS C 4 N added NEW as essential

Page 27: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

27 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

45 NEW

13513808

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 3.5, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 E added NEW as essential

46 NEW

13513809

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 4, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 E added NEW as essential

47 NEW

13513810

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 4.5, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 N added NEW as essential

48 NEW

13513811

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 5, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

49 NEW

13513812

Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JR 6, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 N added NEW as essential

50 NEW

13513813

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 3.5, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

51 NEW

13513814

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 4, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

52 NEW

13513815

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 4.5, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

53 NEW

13513816

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 5, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 E added NEW as essential

54 NEW

13513817

Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JR 6, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 N added NEW as essential

55 NEW

13513818

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 3.5, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

56 NEW

13513819

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 4, 90cm - 100cm length, with out side holes,sterile.

NOS C 4 E added NEW as essential

57 NEW

13513820

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 4.5, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 N added NEW as essential

Page 28: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

28 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

58 NEW

13513821

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 5, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 E added NEW as essential

59 NEW

13513822

Coronary Guiding Catheter, Right, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JR 6, 90cm - 100cm length,with out side holes, sterile.

NOS C 4 N added NEW as essential

60 NEW

13513823

Coronary Guiding Catheter, Right, Judkin type or similar, size 8F, Inner diameter > 0.081", curve style JR 4, 100cm - 110cm length, with/with out side holes,sterile.

NOS C 4 N added NEW as essential

61 NEW

13513824

Coronary Guiding Catheter, Right, Judkin type or similar, size 8F, Inner diameter > 0.081", curve style JR 4.5, 100cm - 110cm length ,with/with out side holes, sterile.

NOS C 4 N added NEW as essential

62 13511300

Coronary Guiding Catheter, Backup Left, size 5F, Inner diameter > 0.058", curve style BL 3, with out side holes, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

63 13511400

Coronary Guiding Catheter, Backup Left, size 5F, Inner diameter > 0.058", curve style BL 3.5, 90cm - 100cm length, with side out holes, sterile.

NOS C 4 N specs amended

64 13511500

Coronary Guiding Catheter, Backup Left, size 5F, Inner diameter > 0.058", curve style BL 4, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

65 13511600

Coronary Guiding Catheter, Backup Left, size 5F, Inner diameter > 0.058", curve style BL 4.5, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

66 13511301

Coronary Guiding Catheter, Backup Left, size 6F, Inner diameter > 0.071", curve style BL 3, with out side holes, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

67 13511401

Coronary Guiding Catheter, Backup Left, size 6F, Inner diameter > 0.071", curve style BL 3.5, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

68 13511501

Coronary Guiding Catheter, Backup Left, size 6F, Inner diameter > 0.071", curve style BL 4, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

69 13511601

Coronary Guiding Catheter, Backup Left, size 6F, Inner diameter > 0.071", curve style BL 4.5, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

70 13511302

Coronary Guiding Catheter, Backup Left, size 7F, Inner diameter > 0.081", curve style BL 3, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

Page 29: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

29 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

71 13511402

Coronary Guiding Catheter, Backup Left, size 7F, Inner diameter > 0.081", curve style BL 3.5, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

72 13511502

Coronary Guiding Catheter, Backup Left, size 7F, Inner diameter > 0.081", curve style BL 4, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

73 13511602

Coronary Guiding Catheter, Backup Left, size 7F, Inner diameter > 0.081", curve style BL 4.5, 90cm - 100cm length, with out side holes, sterile.

NOS C 4 N specs amended

74 13511900 Coronary Guiding Catheter, Ikari Left Curve, size 5F, Inner diameter > 0.058", curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

75 13512000 Coronary Guiding Catheter, Ikari Left Curve, size 5F, Inner diameter > 0.058", curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

76 13511901 Coronary Guiding Catheter, Ikari Left Curve, size 6F, Inner diameter > 0.071", curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

77 13512001 Coronary Guiding Catheter, Ikari Left Curve, size 6F, Inner diameter > 0.071", curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

78 13511902 Coronary Guiding Catheter, Ikari Left Curve, size 7F, Inner diameter > 0.081", curve style IL 3.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

79 13512002 Coronary Guiding Catheter, Ikari Left Curve, size 7F, Inner diameter > 0.081", curve style IL 4, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

80 13512100 Coronary Guiding Catheter, Ikari Left Curve, size 5F, Inner diameter > 0.058", curve style IL 1.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

81 13512200 Coronary Guiding Catheter, Ikari Left Curve, size 5F, Inner diameter > 0.058", curve style IL 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

82 13512101 Coronary Guiding Catheter, Ikari Left Curve, size 6F, Inner diameter > 0.071", curve style IL 1.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

83 13512201 Coronary Guiding Catheter, Ikari Left Curve, size 6F, Inner diameter > 0.071", curve style IL 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

84 13512102 Coronary Guiding Catheter, Ikari Left Curve, size 7F, Inner diameter > 0.081", curve style IL 1.5, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

85 13512202 Coronary Guiding Catheter, Ikari Left Curve, size 7F, Inner diameter > 0.081", curve style IL 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

86 13512300 Coronary Guiding Catheter, Internal Mammary Artery, size 5F, Inner diameter > 0.058", curve style IMA 1, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

87 13512301 Coronary Guiding Catheter, Internal Mammary Artery, size 6F, Inner diameter > 0.071", curve style IMA 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

Page 30: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

30 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

88 13512302 Coronary Guiding Catheter, Internal Mammary Artery, size 7F, Inner diameter > 0.081", curve style IMA 2, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

89 13513900 Coronary Guiding Catheter, multipurpose, size 5F, Inner diameter > 0.058", curve style MP L, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

90 13513901 Coronary Guiding Catheter, multipurpose, size 6F, Inner diameter > 0.071", curve style MP L, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

91 13513902 Coronary Guiding Catheter, multipurpose, size 7F, Inner diameter > 0.081", curve style MP L, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

92 13511700 Coronary Guiding Catheter, Bypass Left, size 5F, Inner diameter > 0.058", curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

93 13511701 Coronary Guiding Catheter, Bypass Left, size 6F, Inner diameter > 0.071", curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

94 13511702 Coronary Guiding Catheter, Bypass Left, size 7F, Inner diameter > 0.081", curve style BP L, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

95 13511800 Coronary Guiding Catheter, Bypass Right, size 5F, Inner diameter > 0.058", curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

96 13511801 Coronary Guiding Catheter, Bypass Right, size 6F, Inner diameter > 0.071", curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 E specs amended

97 13511802 Coronary Guiding Catheter, Bypass Right, size 7F, Inner diameter > 0.081", curve style BP R, 90cm - 100cm length, sterile.

NOS C 4 N specs amended

98 NEW

13513002

Coronary Guiding Catheter, Extra Support type, size 6F, curve style XB 3, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

99 NEW

13513003

Coronary Guiding Catheter, Extra Support type, size 6F, curve style XB 3.5, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

100 NEW

13513004

Coronary Guiding Catheter, Extra Support type, size 6F, curve style XB 4, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

101 NEW

13513005

Coronary Guiding Catheter, Extra Support type, size 7F, curve style XB 3, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

102 NEW

13513006

Coronary Guiding Catheter, Extra Support type, size 7F, curve style XB 3.5, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

103 NEW

13513007

Coronary Guiding Catheter, Extra Support type, size 7F, curve style XB 4, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

104 NEW

13513102

Coronary Guiding Catheter, Extra Backup type (EBU), size 6F, curve style EBU 3.0, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

Page 31: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

31 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

105 NEW

13513103

Coronary Guiding Catheter, Extra Backup type (EBU), size 6F, curve style EBU 3.5, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

106 NEW

13513104

Coronary Guiding Catheter, Extra Backup type (EBU), size 6F, curve style EBU 4.0, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

107 NEW

13513105

Coronary Guiding Catheter, Extra Backup type (EBU), size 7F, curve style EBU 3.0, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

108 NEW

13513106

Coronary Guiding Catheter, Extra Backup type (EBU), size 7F, curve style EBU 3.5, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

109 NEW

13513107

Coronary Guiding Catheter, Extra Backup type (EBU), size 7F, curve style EBU 4.0, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

110 NEW

13513202

Coronary Guiding Catheter, VODA type, size 6F, curve style VODA 3, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

111 NEW

13513203

Coronary Guiding Catheter, VODA type, size 6F, curve style VODA 4, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

112 NEW

13513204

Coronary Guiding Catheter, VODA type, size 7F, curve style VODA 3, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

113 NEW

13513205

Coronary Guiding Catheter, VODA type, size 7F, curve style VODA 4, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

114 NEW

13513206

Coronary Guiding Catheter, Radial, size 6F, 90cm - 100cm length, sterile. NOS C 4 N

added NEW as essential

115 NEW

13513207

Coronary Guiding Catheter, Launcher type, size 6F, 90cm - 100cm length, sterile. NOS C 4 N

added NEW as essential

116 NEW

13513208

Coronary Guiding Catheter, Launcher type, size 7F, 90cm - 100cm length, sterile. NOS C 4 N

added NEW as essential

117 NEW

13513209

Coronary Guiding Catheter, Right, Launcher type, size 6F, curve style JR 3.5, 90cm - 100cm length, sterile.

NOS C 4 N added NEW as essential

118 NEW

13513210

Coronary Guiding Catheter, Hockey Stick type, size 6F, 90cm - 100cm length, sterile. NOS C 4 N

added NEW as essential

119 NEW

13513211

Coronary Guiding Catheter, Hockey Stick type, size 7F, 90cm - 100cm length, sterile. NOS C 4 N

added NEW as essential

120 NEW

13513212

Coronary Guiding Catheter, Coronary Micro type, size 1.8F, 130cm (approx.) length, sterile. NOS C 4 N

added NEW as essential

121 NEW

13513213

Coronary Guiding Catheter, Coronary Micro type, size 1.8F, 150cm (approx.) length, sterile. NOS C 4 N

added NEW as essential

Page 32: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

32 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

122 NEW

13513214

Double Lumen Coronary Guiding Catheter, Coronary Micro type size 3.2F,140cm,Crusade type or similar.

NOS C 4 N added NEW as essential

123 NEW

13513215

Guidesilla- Guide Extention Catheter,6F,25cm,Boston Scientific or similar. NOS C 4 N

added NEW as essential

124 NEW

13513216

Guide liner-Extention Catheter,6F-25cm,Boston Scientific or similar. NOS C 4 N

added NEW as essential

DELETED ITEMS

1 13509800 Coronary Guiding Catheter, Left, Amplazter type or similar, size 4F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

2 13509900 Coronary Guiding Catheter, Left, Amplazter type or similar, size 4F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

3 13510800 Coronary Guiding Catheter, Left, Amplazter type or similar, size 4F, curve style AL 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

4 13510900 Coronary Guiding Catheter, Left, Amplazter type or similar, size 4F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

5 13511000 Coronary Guiding Catheter, Right, Amplazter type or similar, size 4F, curve style AR 1, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

6 13511100 Coronary Guiding Catheter, Right, Amplazter type or similar, size 4F, curve style AR 2, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

7 13511200 Coronary Guiding Catheter, Right, Amplazter type or similar, size 4F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

8 13509802 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, curve style AL 1, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

9 13509902 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, curve style AL 2, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

10 13510802 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, curve style AL 3, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

11 13510901 Coronary Guiding Catheter, Left, Amplazter type or similar, size 5F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

12 13509903 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 2, 100cm - 110cm length, sterile.

NOS C 4 E Deleted

13 13509904 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 2, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

14 13509803 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 1, 100cm - 110cm length, sterile.

NOS C 4 E Deleted

Page 33: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

33 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

15 13509804 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 1, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

16 13510804 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 3, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

17 13510902 Coronary Guiding Catheter, Left, Amplazter type or similar, size 6F, curve style AL 4, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

18 13511002 Coronary Guiding Catheter, Right, Amplazter type or similar, size 5F, curve style AR 1, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

19 13511004 Coronary Guiding Catheter, Right, Amplazter type or similar, size 6F, curve style AR 1, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

20 13511104 Coronary Guiding Catheter, Right, Amplazter type or similar, size 6F, curve style AR 2, 80cm - 95cm length, sterile.

NOS C 4 E Deleted

21 13511202 Coronary Guiding Catheter, Right, Amplazter type or similar, size 6F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

22 13511102 Coronary Guiding Catheter, Right, Amplazter type or similar, size 5F, curve style AR 2, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

23 13511201 Coronary Guiding Catheter, Right, Amplazter type or similar, size 5F, curve style AR 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

24 13512400 Coronary Guiding Catheter, Left, Judkin type or similar, size 4F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 E Deleted

25 13512500 Coronary Guiding Catheter, Left, Judkin type or similar, size 4F, curve style JL 3.5, 100cm - 110cm length, sterile.

NOS C 4 E Deleted

26 13512600 Coronary Guiding Catheter, Left, Judkin type or similar, size 4F, curve style JL 4, 100cm - 110cm length, sterile.

NOS C 4 E Deleted

27 13512800 Coronary Guiding Catheter, Left, Judkin type or similar, size 4F, curve style JL 5, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

28 13512900 Coronary Guiding Catheter, Left, Judkin type or similar, size 4F, curve style JL 6, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

29 13512401 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

30 13512503 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, curve style JL 3.5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

31 13512803 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, curve style JL 5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

Page 34: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

34 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

32 13512903 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, curve style JL 6, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

33 13512402 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, curve style JL 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

34 13512504 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, curve style JL 3.5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

35 13512603 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, curve style JL 4, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

36 13512804 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, curve style JL 5, 80cm - 95cm length, sterile.

NOS C 4 E Deleted

37 13512904 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, curve style JL 6, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

38 13512506 Coronary Guiding Catheter, Left, Judkin type or similar, size 8F, curve style JL 3.5, 80cm - 95cm length, sterile.

NOS C 4 E Deleted

39 13513000 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

40 13513100 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

41 13513200 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

42 13513300 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

43 13513400 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 3.5, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

44 13513500 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 4, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

45 13513700 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 5, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

46 13513800 Coronary Guiding Catheter, Right, Judkin type or similar, size 4F, curve style JR 6, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

47 13513001 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 1.5, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

48 13513101 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 2, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

Page 35: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

35 List 03

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

49 13513201 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 2.5, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

50 13513303 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

51 13513302 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 3, 60cm - 80cm length, sterile.

NOS C 4 N Deleted

52 13513403 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 3.5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

53 13513503 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 4, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

54 13513504 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 4, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

55 13513703 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

56 13513803 Coronary Guiding Catheter, Right, Judkin type or similar, size 5F, curve style JR 6, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

57 13513304 Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, curve style JR 3, 100cm - 110cm length, sterile.

NOS C 4 N Deleted

58 13513404 Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, curve style JR 3.5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

59 13513704 Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, curve style JR 5, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

60 13513804 Coronary Guiding Catheter, Right, Judkin type or similar, size 6F, curve style JR 6, 80cm - 95cm length, sterile.

NOS C 4 N Deleted

61 13513506 Coronary Guiding Catheter, Right, Judkin type or similar, size 8F, curve style JR 4, 80cm - 95cm length, sterile.

NOS C 4 E Deleted

62 13512901 Coronary Guiding Catheter, Left, Judkin type or similar, size 5F, Inner diameter > 0.058", curve style JL 6, 90cm - 100cm length, sterile.

NOS C 4 N Deleted

63 13512902 Coronary Guiding Catheter, Left, Judkin type or similar, size 6F, Inner diameter > 0.071", curve style JL 6, 90cm - 100cm length, sterile.

NOS C 4 N Deleted

64 13512905 Coronary Guiding Catheter, Left, Judkin type or similar, size 7F, Inner diameter > 0.081", curve style JL 6, 90cm - 100cm length, sterile.

NOS C 4 N Deleted

Page 36: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

36 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

BALLOON CATHETERS

1 13516400

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 4mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

2 13516401

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 5mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

3 13516402

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 6mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

4 13516403

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 7mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

5 13516404

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 8mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

6 13516700

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 8mm x 3cm, compatible with size 4F/5F introducer sheath, sterile.

NOS C 4 E continue

7 13516500

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 9mm x 2cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

8 13516701

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 9mm x 3cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

9 13516501

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 10mm x 2cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 E continue

10 13516702

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 10mm x 3cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

11 13516502

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 12mm x 2cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 E continue

Page 37: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

37 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

12 13516703

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 12mm x 3cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

13 13516600

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 13mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

14 13516800

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 13mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

15 13517300

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 13mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

16 13516601

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 14mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

17 13516900

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 14mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 E continue

18 13517400

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 14mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

19 13516901

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 15mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

20 13517401

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 15mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

21 13516902

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 16mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

22 13517402

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 16mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

23 13516903

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 17mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

24 13517403

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 17mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

Page 38: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

38 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

25 13517000

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 18mm x 3cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

26 13517500

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 18mm x 4cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

27 13517001

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 20mm x 3cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

28 13517501

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 20mm x 4cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

29 13517002

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 22mm x 3cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

30 13517502

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 22mm x 4cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

31 13517100

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 23mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

32 13517600

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 23mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

33 13517101

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 25mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

34 13517601

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 25mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

35 13517200

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 30mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

36 13517700

Balloon Dilatation Catheter for Valvuloplasty, low profile, Tyshak II type or similar, size 30mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

37 13517800

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 3mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

Page 39: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

39 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

38 13518100

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 3mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

39 13517801

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 4mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

40 NEW

13517803

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 4mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 E added NEW as essential

41 13517802

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 5mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

42 13518101

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 5mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

43 13517900

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 6mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

44 13518300

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 6mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

45 13517901

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 7mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

46 13518301

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 7mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

47 13517902

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 8mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

48 13518302

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 8mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

49 13517903

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 9mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

50 13518303

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 9mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

Page 40: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

40 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

51 13517904

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 10mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

52 13518304

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 10mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

53 13517905

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 11mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

54 13518305

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 11mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

55 13518000

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 12mm x 2cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

56 13518400

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 12mm x 3cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N continue

57 13518500

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 14mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

58 13518800

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 14mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

59 13518501

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 15mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

60 13518801

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 15mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

61 13518502

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 16mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

62 13518802

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 16mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

63 13518600

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 17mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

Page 41: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

41 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

64 13518900

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 17mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

65 13518601

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 18mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

66 13518901

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 18mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

67 13518700

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 20mm x 3cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

68 13519000

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 20mm x 4cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

69 13518701

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 22mm x 3cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

70 13519001

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 22mm x 4cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

71 NEW

13521301

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 12mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 E added NEW as essential

72 13521300

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 12mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N continue

73 13520700

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 14mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

74 13521400

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 14mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

75 13520701

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 15mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

76 13521401

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 15mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N continue

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42 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

77 13520800

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 16mm x 3cm, compatible with size 11F introducer sheath, sterile.

NOS C 4 N continue

78 13521500

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 16mm x 4cm, compatible with size 11F introducer sheath, sterile.

NOS C 4 N continue

79 13520900

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 18mm x 3cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

80 13521600

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 18mm x 4cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N continue

81 13521000

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 20mm x 3cm, compatible with size 13F introducer sheath, sterile.

NOS C 4 N continue

82 13521700

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 20mm x 4cm, compatible with size 13F introducer sheath, sterile.

NOS C 4 N continue

83 13521100

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 22mm x 3cm, compatible with size 14F introducer sheath, sterile.

NOS C 4 N continue

84 13521800

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 22mm x 4cm, compatible with size 14F introducer sheath, sterile.

NOS C 4 N continue

85 13521101

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 23mm x 3cm, compatible with size 14F introducer sheath, sterile.

NOS C 4 N continue

86 13521801

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 23mm x 4cm, compatible with size 14F introducer sheath, sterile.

NOS C 4 N continue

87 13521200

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 25mm x 3cm, compatible with size 16F introducer sheath, sterile.

NOS C 4 N continue

88 13521900

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Mullin type or similar, size 25mm x 4cm, compatible with size 16F introducer sheath, sterile.

NOS C 4 N continue

89 13519100

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 4mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

Page 43: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

43 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

90 13519500

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 4mm x 3cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

91 13519101

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 5mm x 2cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

92 13519501

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 5mm x 3cm, compatible with size 4F introducer sheath, sterile.

NOS C 4 N continue

93 13519200

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 6mm x 2cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

94 13519600

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 6mm x 3cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

95 13519201

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 7mm x 2cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

96 13519601

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 7mm x 3cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

97 13519900

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 7mm x 4cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N continue

98 13519300

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 8mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

99 13519700

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 8mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

100 13520000

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 8mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

101 13519301

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 9mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

102 13519701

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 9mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

Page 44: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

44 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

103 13520001

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 9mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

104 13519302

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 10mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

105 13519702

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 10mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

106 13520002

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 10mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

107 13519303

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 11mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

108 13519703

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 11mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

109 13520003

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 11mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N continue

110 13519400

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 12mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

111 13519800

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 12mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

112 13520600

Balloon Dilatation Catheter for Valvuloplasty, Paediatric, high pressure, Numed Coefficient type or similar, size 12mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N continue

113 13522000

Balloon Dilatation Catheter for Septostomy, (Rashkind septostomy balloon), Medtronic type or similar, size 5F, compatible with size 5F - 7F introducer sheath, sterile.

NOS C 4 N continue

114 13522001

Balloon Dilatation Catheter for Septostomy, (Rashkind septostomy balloon), Medtronic type or similar, size 6F, compatible with size 5F - 7F introducer sheath, sterile.

NOS C 4 N continue

115 13522100

Balloon Dilatation Catheter for Septostomy, over the wire type, (Atrioseptostomy), Numed Z5 Atrioseptostomy type or similar, size 9.5mm x 0.95cm, compatible with size 5F introducer sheath, sterile.

NOS C 4 N specs amended

Page 45: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

45 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

116 13522101

Balloon Dilatation Catheter for Septostomy, over the wire type, (Atrioseptostomy), Numed Z5 Atrioseptostomy type or similar, size 13.5mm x 1.35cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N specs amended

117 13522200

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Toray Inoue balloon type or similar, size 20mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 E specs amended

118 13522201

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Toray Inoue balloon type or similar, size 22mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 E specs amended

119 13522203

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Toray Inoue balloon type or similar, size 24mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 E specs amended

120 13522204

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Toray Inoue balloon type or similar, size 26mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 E specs amended

121 13522205

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Toray Inoue balloon type or similar, size 28mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 E specs amended

122 13523800

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion type, size 1.00mm x 10mm, sterile.

NOS C 4 N continue

123 13523801

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion type, size 1.25mm x 10mm, sterile.

NOS C 4 N continue

124 13523802

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion type, size 1.5mm x 10mm, sterile.

NOS C 4 N continue

125 13522500 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2mm x 8mm, sterile.

NOS C 4 E continue

126 13522501 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2mm x 10mm, sterile.

NOS C 4 E continue

127 13522502 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2mm x 15mm, sterile.

NOS C 4 N continue

128 13522600 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.25mm x 10mm, sterile.

NOS C 4 N continue

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46 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

129 13522601 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.25mm x 15mm, sterile.

NOS C 4 N continue

130 13522700 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 8mm, sterile.

NOS C 4 E continue

131 13522701 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 10mm, sterile.

NOS C 4 E continue

132 13522702 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 12mm, sterile.

NOS C 4 N continue

133 13522703 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 15mm, sterile.

NOS C 4 E continue

134 13523200 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.5mm x 8mm, sterile.

NOS C 4 N continue

135 13523201 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.5mm x 10mm, sterile.

NOS C 4 E continue

136 13523300 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.75mm x 8mm, sterile.

NOS C 4 E continue

137 13523301 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.75mm x 10mm, sterile.

NOS C 4 E continue

138 13523302 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.75mm x 12mm, sterile.

NOS C 4 E continue

139 13523303 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 2.75mm x 15mm, sterile.

NOS C 4 N continue

140 13523400 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.0mm x 8mm, sterile.

NOS C 4 N continue

141 13523401 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.0mm x 10mm, sterile.

NOS C 4 E continue

142

13523403 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.0mm x 12mm, sterile.

NOS C 4 E continue

Page 47: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

47 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

143 13523402 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.0mm x 15mm, sterile.

NOS C 4 N continue

144 13523500 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.25mm x 8mm, sterile.

NOS C 4 E continue

145 13523501 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.25mm x 10mm, sterile.

NOS C 4 N continue

146 13523502 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.25mm x 12mm, sterile.

NOS C 4 E continue

147 13523503 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.25mm x 15mm, sterile.

NOS C 4 N continue

148 13523600 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.5mm x 8mm, sterile.

NOS C 4 E continue

149 13523601 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.5mm x 10mm, sterile.

NOS C 4 N continue

150 13523602 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.5mm x 12mm, sterile.

NOS C 4 N continue

151 13523700 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 4mm x 8mm, sterile.

NOS C 4 N continue

152 NEW

13523702

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 4.5mm x 8mm, sterile.

NOS C 4 N added NEW as essential

153 NEW

13522401

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.0mm x 8mm, sterile.

NOS C 4 N added NEW as essential

154 NEW

13522402

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.0mm x 10mm, sterile.

NOS C 4 N added NEW as essential

155 NEW

13522403

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.25mm x 8mm, sterile.

NOS C 4 N added NEW as essential

156 NEW

13522404

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.25mm x 10mm, sterile.

NOS C 4 N added NEW as essential

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48 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

157 NEW

13522405

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.5mm x 8mm, sterile.

NOS C 4 N added NEW as essential

158 NEW

13522406

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), over the wire type, size 2.5mm x 10mm, sterile.

NOS C 4 N added NEW as essential

159 NEW

13522102

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 3mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

160 NEW

13522103

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 3mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

161 NEW

13522104

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 4mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

162 NEW

13522105

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 4mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

163 NEW

13522106

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 5mm x 2cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

164 NEW

13522107

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 5mm x 3cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N added NEW as essential

165 NEW

13522108

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 6mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

166 NEW

13522109

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 6mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

167 NEW

13522110

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 7mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

Page 49: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

49 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

168 NEW

13522111

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 7mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

169 NEW

13522112

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 8mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

170 NEW

13522113

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 8mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

171 NEW

13522114

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 9mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

172 NEW

13522115

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 9mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

173 NEW

13522116

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 10mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

174 NEW

13522117

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 10mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

175 NEW

13522118

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 11mm x 2cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

176 NEW

13522119

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 11mm x 3cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N added NEW as essential

177 NEW

13522120

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 12mm x 2cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N added NEW as essential

Page 50: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

50 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

178 NEW

13522121

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 12mm x 3cm, compatible with size 8F introducer sheath, sterile.

NOS C 4 N added NEW as essential

179 NEW

13522122

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 14mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

180 NEW

13522123

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 14mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

181 NEW

13522124

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 15mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

182 NEW

13522125

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 15mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

183 NEW

13522126

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 16mm x 3cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

184 NEW

13522127

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 16mm x 4cm, compatible with size 9F introducer sheath, sterile.

NOS C 4 N added NEW as essential

185 NEW

13522128

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 17mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N added NEW as essential

186 NEW

13522129

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 17mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N added NEW as essential

187 NEW

13522130

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 18mm x 3cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N added NEW as essential

Page 51: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

51 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

188 NEW

13522131

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 18mm x 4cm, compatible with size 10F introducer sheath, sterile.

NOS C 4 N added NEW as essential

189 NEW

13522132

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 20mm x 3cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N added NEW as essential

190 NEW

13522133

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 20mm x 4cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N added NEW as essential

191 NEW

13522134

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 22mm x 3cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N added NEW as essential

192 NEW

13522135

Balloon in Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Neumed type, size 22mm x 4cm, compatible with size 12F introducer sheath, sterile.

NOS C 4 N added NEW as essential

193 NEW

13523101

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.0 x 10mm length,sterile.

NOS C 4 N added NEW as essential

194 NEW

13523102

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.0 x 15mm length,sterile.

NOS C 4 N added NEW as essential

195 NEW

13523103

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.0 x 20mm length,sterile.

NOS C 4 N added NEW as essential

196 NEW

13523104

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.5 x 10mm length,sterile.

NOS C 4 N added NEW as essential

197 NEW

13523105

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.5 x 15mm length,sterile.

NOS C 4 N added NEW as essential

198 NEW

13523106

High pressure non-compliance Balloon Dilatation Cathter, diameter 2.5 x 20mm length,sterile.

NOS C 4 N added NEW as essential

199 NEW

13523107

High pressure non-compliance Balloon Dialatation Cathter, diameter 3.0 x 10mm length, sterile.

NOS C 4 N added NEW as essential

200 NEW

13523108

High pressure non-compliance Balloon Dialatation Cathter, diameter 3.0 x 15mm length,sterile.

NOS C 4 N added NEW as essential

201 NEW

13523109

High pressure non-compliance Balloon Dilatation Cathter, diameter 3.0 x 20mm length,sterile.

NOS C 4 N added NEW as essential

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52 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

202 NEW

13523110

High pressure non-compliance Balloon Dilatation Cathter, diameter 3.5 x 10mm length,sterile.

NOS C 4 N added NEW as essential

203 NEW

13523111

High pressure non-compliance Balloon Dialatation Cathter, diameter 3.5 x 15mm length,sterile.

NOS C 4 N added NEW as essential

204 NEW

13523112

High pressure non-compliance Balloon Dialatation Cathter, diameter 3.5 x 20mm length,sterile.

NOS C 4 N added NEW as essential

205 NEW

13523113

High pressure non-compliance Balloon Dialatation Cathter, diameter 4.0 x 10mm length,sterile.

NOS C 4 N added NEW as essential

206 NEW

13523114

High pressure non-compliance Balloon Dilatation Cathter, diameter 4.0 x 15mm length,sterile.

NOS C 4 N added NEW as essential

207 NEW

13523115

High pressure non-compliance Balloon Dilatation Cathter, diameter 4.0 x 20mm length,sterile.

NOS C 4 N added NEW as essential

DELETED ITEMS

1 13522503

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2mm x 12mm balloon, sterile.

NOS C 4 N

2 13522602

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.25mm x 20mm balloon, sterile.

NOS C 4 N

3 13522704

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 18mm balloon, sterile.

NOS C 4 N

4 13522705

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.5mm x 20mm balloon, sterile.

NOS C 4 E

5 13522801

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 10mm balloon, sterile.

NOS C 4 N

6 13522802

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 12mm balloon, sterile.

NOS C 4 N

7 13522803

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 15mm balloon, sterile.

NOS C 4 N

8 13522804

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 18mm balloon, sterile.

NOS C 4 E

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53 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

9 13522805

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 20mm balloon, sterile.

NOS C 4 N

10 13522800

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 2.75mm x 8mm balloon, sterile.

NOS C 4 N

11 13522901

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 10mm balloon, sterile.

NOS C 4 N

12 13522902

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 12mm balloon, sterile.

NOS C 4 N

13 13522903

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 15mm balloon, sterile.

NOS C 4 N

14 13522904

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 18mm balloon, sterile.

NOS C 4 N

15 13522905

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 20mm balloon, sterile.

NOS C 4 E

16 13522900

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.0mm x 8mm balloon, sterile.

NOS C 4 N

17 13523001

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.5mm x 10mm balloon, sterile.

NOS C 4 N

18 13523000

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 3.5mm x 8mm balloon, sterile.

NOS C 4 N

19 13523100

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), compliance type, size 4.0mm x 8mm balloon, sterile.

NOS C 4 N

20 13523403

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 3.0mm x 12mm balloon, sterile. NOS

C 4 N

21 13523701

Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), non compliance type, size 4mm x 10mm balloon, sterile. NOS

C 4 N

Page 54: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

54 List 04

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

22 13522300

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Accura type or similar, size 17mm -20mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 N

23 13522301

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Accura type or similar, size 22mm -24mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 N

24 13522302

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Accura type or similar, size 24mm -26mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 N

25 13522304

Balloon Catheter for Percutaneous Transluminal Mitral Commissurotomy (PTMC), Accura type or similar, size 26mm -28mm x 70cm, compatible with size 12Fr introducer sheath, sterile.

NOS C 4 N

26

13523803 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion type, size 1.5mm x 8mm balloon, sterile.

NOS C 4 N

27

13523804 Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion type, size 1.0mm x 8mm balloon, sterile.

NOS C 4 N

28 13520601

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Numed Coefficient type or similar, size 12mm x 4cm, compatible with size 7F introducer sheath, sterile.

NOS C 4 N

29 13518200

Balloon Dilatation Catheter for Valvuloplasty, high pressure, Z Med type or similar, size 3mm x 4cm, compatible with size 6F introducer sheath, sterile.

NOS C 4 N

Page 55: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

55 List 05

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

CORONARY STENTS

1 13510401 Coronary Stent, bare metal, size 2.5mm diameter balloon, 8mm/9mm length, premounted, sterile.

NOS C 4 E continue

2 13510402 Coronary Stent, bare metal, size 2.5mm diameter balloon, 10mm - 12mm length, premounted, sterile.

NOS C 4 E continue

3 13510403 Coronary Stent, bare metal, size 2.5mm diameter balloon, 13mm - 15mm length, premounted, sterile.

NOS C 4 E continue

4 13510404 Coronary Stent, bare metal, size 2.5mm diameter balloon, 16mm - 18mm length, premounted, sterile.

NOS C 4 E continue

5 13510501 Coronary Stent, bare metal, size 2.75mm diameter balloon, 8mm/9mm length, premounted, sterile.

NOS C 4 E continue

6 13510502 Coronary Stent, bare metal, size 2.75mm diameter balloon, 10mm - 12mm length, premounted, sterile.

NOS C 4 E continue

7 13510503 Coronary Stent, bare metal, size 2.75mm diameter balloon, 13mm - 15mm length, premounted, sterile.

NOS C 4 E continue

8 13510504 Coronary Stent, bare metal, size 2.75mm diameter balloon, 16mm - 18mm length, premounted, sterile.

NOS C 4 E continue

9 13501374 Coronary Stent, bare metal, size 2.75mm diameter balloon, 19mm - 21mm length, premounted, sterile.

NOS C 4 E continue

10 13510505 Coronary Stent, bare metal, size 2.75mm diameter balloon, 22mm - 24mm length, premounted, sterile.

NOS C 4 E continue

11 13510506 Coronary Stent, bare metal, size 2.75mm diameter balloon, 25mm - 28mm length, premounted, sterile.

NOS C 4 E continue

12 13510601 Coronary Stent, bare metal, size 3.00mm diameter balloon, 8mm/9mm length, premounted, sterile.

NOS C 4 E continue

13 13510602 Coronary Stent, bare metal, size 3.00mm diameter balloon, 10mm - 12mmlength, premounted, sterile.

NOS C 4 E continue

14 13510603 Coronary Stent, bare metal, size 3.00mm diameter balloon, 13mm - 15mm length, premounted, sterile.

NOS C 4 E continue

Page 56: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

56 List 05

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

15 13510604 Coronary Stent, bare metal, size 3.00mm diameter balloon, 16mm - 18mm length, premounted, sterile.

NOS C 4 E continue

16 13510605 Coronary Stent, bare metal, size 3.00mm diameter balloon, 19mm-21mm length, premounted, sterile.

NOS C 4 E continue

17 13510606 Coronary Stent, bare metal, size 3.00mm diameter balloon, 22mm - 24mm length, premounted, sterile.

NOS C 4 E continue

18 13510607 Coronary Stent, bare metal, size 3.00mm diameter balloon, 25mm - 28mm length, premounted, sterile.

NOS C 4 E continue

19 13510701 Coronary Stent, bare metal, size 3.5mm diameter balloon, 8mm/9mm length, premounted, sterile.

NOS C 4 E continue

20 13510702 Coronary Stent, bare metal, size 3.5mm diameter balloon, 10mm - 12mm length, premounted, sterile.

NOS C 4 E continue

21 13510703 Coronary Stent, bare metal, size 3.5mm diameter balloon, 13mm - 15mm length, premounted, sterile.

NOS C 4 E continue

22 13510704 Coronary Stent, bare metal, size 3.5mm diameter balloon, 16mm - 18mm length, premounted, sterile.

NOS C 4 E continue

23 13510705 Coronary Stent, bare metal, size 3.5mm diameter balloon, 19mm - 21mm length, premounted, sterile.

NOS C 4 E continue

24 13510706 Coronary Stent, bare metal, size 3.5mm diameter balloon, 22mm - 24mm length, premounted, sterile.

NOS C 4 E continue

25 NEW 13510707

Coronary Stent, bare metal, size 3.5mm diameter balloon, 25mm - 28mm length, premounted, sterile.

NOS C 4 E added NEW as essential

26 NEW 13501415

Drug Eluting Coronary Stent, 2.25 mm diameter,12-15 mm length,sterile.

NOS C 4 E added NEW as essential

27 NEW 13501416

Drug Eluting Coronary Stent, 2.25 mm diameter,16-18 mm length,sterile.

NOS C 4 E added NEW as essential

28 NEW 13501417

Drug Eluting Coronary Stent, 2.25 mm diameter,22-25 mm length,sterile.

NOS C 4 E added NEW as essential

29 NEW 13501418

Drug Eluting Coronary Stent, 2.25 mm diameter,28-33 mm length,sterile.

NOS C 4 E added NEW as essential

30 NEW 13501408

Drug Eluting Coronary Stent, 2.5 mm diameter,12-15 mm length,sterile.

NOS C 4 E added NEW as essential

31 NEW 13501405

Drug Eluting Coronary Stent, 2.5 mm diameter,16-18 mm length,sterile.

NOS C 4 E added NEW as essential

32 NEW 13501409

Drug Eluting Coronary Stent, 2.5 mm diameter,19-21 mm length,sterile.

NOS C 4 E added NEW as essential

33 NEW 13501410

Drug Eluting Coronary Stent, 2.5 mm diameter,22-24 mm length,sterile.

NOS C 4 E added NEW as essential

34 NEW 13501411

Drug Eluting Coronary Stent, 2.5 mm diameter,25-27mm length,sterile.

NOS C 4 E added NEW as essential

35 NEW 13501402

Drug Eluting Coronary Stent, 2.5 mm diameter,28-30mm length,sterile.

NOS C 4 E added NEW as essential

Page 57: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

57 List 05

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

36 NEW 13501412

Drug Eluting Coronary Stent, 2.5 mm diameter,31-33 mm length,sterile.

NOS C 4 E added NEW as essential

37 NEW 13501413

Drug Eluting Coronary Stent, 2.5 mm diameter,38 mm length,sterile.

NOS C 4 E added NEW as essential

38 NEW 13501414

Drug Eluting Coronary Stent, 2.5 mm diameter,48 mm length,sterile.

NOS C 4 E added NEW as essential

39 NEW 13501509

Drug Eluting Coronary Stent, 2.75 mm diameter,16-18 mm length,sterile.

NOS C 4 E added NEW as essential

40 NEW 13501510

Drug Eluting Coronary Stent, 2.75 mm diameter,19-21 mm length,sterile.

NOS C 4 E added NEW as essential

41 13501501 Drug Eluting Coronary Stent, 2.75 mm diameter,22-23 mm length,sterile.

NOS C 4 E specs amended.

42 13501502 Drug Eluting Coronary Stent, 2.75 mm diameter,24-25 mm length,sterile.

NOS C 4 E specs amended.

43 13501503 Drug Eluting Coronary Stent, 2.75 mm diameter,26-27 mm length,sterile.

NOS C 4 E specs amended.

44 13501504 Drug Eluting Coronary Stent, 2.75 mm diameter,28-29 mm length,sterile.

NOS C 4 E specs amended.

45 13501505 Drug Eluting Coronary Stent, 2.75 mm diameter,30-31mm length,sterile.

NOS C 4 E specs amended.

46 13501506 Drug Eluting Coronary Stent, 2.75 mm diameter,32-33 mm length,sterile.

NOS C 4 E specs amended.

47 13501507 Drug Eluting Coronary Stent,2.75 mm diameter,38mm length,sterile.

NOS C 4 E continue

48 13501508 Drug Eluting Coronary Stent,2.75 mm diameter,48mm length,sterile.

NOS C 4 E continue

49 13501601 Drug Eluting Coronary Stent, 3.0 mm diameter,16-17mm length,sterile.

NOS C 4 E specs amended.

50 13501602 Drug Eluting Coronary Stent, 3.0 mm diameter,18-19mm length,sterile.

NOS C 4 E specs amended.

51 13501603 Drug Eluting Coronary Stent, 3.0 mm diameter,20-21mm length,sterile.

NOS C 4 E specs amended.

52 NEW 13501612

Drug Eluting Coronary Stent, 3.0 mm diameter,22-23mm length,sterile.

NOS C 4 E added NEW as essential

53 13501604 Drug Eluting Coronary Stent, 3.0 mm diameter,24-25mm length,sterile.

NOS C 4 E specs amended.

54 13501605 Drug Eluting Coronary Stent, 3.0 mm diameter,26-27mm length,sterile.

NOS C 4 E specs amended.

55 13501401 Drug Eluting Coronary Stent, 3.0 mm diameter,28-29mm length,sterile.

NOS C 4 E specs amended.

56 13501606 Drug Eluting Coronary Stent, 3.0 mm diameter,30-31mm length,sterile.

NOS C 4 E specs amended.

57 NEW 13501613

Drug Eluting Coronary Stent, 3.0 mm diameter,32-33mm length,sterile.

NOS C 4 E added NEW as essential

58 13501607 Drug Eluting Coronary Stent, 3.0 mm diameter,34-35mm length,sterile.

NOS C 4 E specs amended.

59 13501608 Drug Eluting Coronary Stent, 3.0 mm diameter,36-37mm length,sterile.

NOS C 4 E specs amended.

60 13501609 Drug Eluting Coronary Stent, 3.0 mm diameter,38mm length,sterile.

NOS C 4 E continue

61 13501610 Drug Eluting Coronary Stent, 3.0 mm diameter,40mm length,sterile.

NOS C 4 E added NEW as essential

Page 58: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

58 List 05

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

62 NEW 13501611

Drug Eluting Coronary Stent, 3.0 mm diameter,48mm length,sterile.

NOS C 4 E added NEW as essential

63 NEW 13501701

Drug Eluting Coronary Stent, 3.5 mm diameter,12-15mm length,sterile.

NOS C 4 E added NEW as essential

64 NEW 13501702

Drug Eluting Coronary Stent, 3.5 mm diameter,16-18mm length,sterile.

NOS C 4 E added NEW as essential

65 NEW 13501703

Drug Eluting Coronary Stent, 3.5 mm diameter,19-21mm length,sterile.

NOS C 4 E added NEW as essential

66 NEW 13501704

Drug Eluting Coronary Stent, 3.5 mm diameter,22-23mm length,sterile.

NOS C 4 E added NEW as essential

67 NEW 13501705

Drug Eluting Coronary Stent, 3.5 mm diameter,24-25mm length,sterile.

NOS C 4 E added NEW as essential

68 NEW 13501706

Drug Eluting Coronary Stent, 3.5 mm diameter,26-27mm length,sterile.

NOS C 4 E added NEW as essential

69 NEW 13501707

Drug Eluting Coronary Stent, 3.5 mm diameter,28-29mm length,sterile.

NOS C 4 E added NEW as essential

70 NEW 13501708

Drug Eluting Coronary Stent, 3.5 mm diameter,30-31mm length,sterile.

NOS C 4 E added NEW as essential

71 NEW 13501709

Drug Eluting Coronary Stent, 3.5 mm diameter,32-33mm length,sterile.

NOS C 4 E added NEW as essential

72 NEW 13501710

Drug Eluting Coronary Stent, 3.5 mm diameter,37-38mm length,sterile.

NOS C 4 E added NEW as essential

73 NEW 13501801

Drug Eluting Coronary Stent, 4.0 mm diameter,12-13mm length,sterile.

NOS C 4 E added NEW as essential

74 NEW 13501802

Drug Eluting Coronary Stent, 4.0 mm diameter,14-15mm length,sterile.

NOS C 4 E added NEW as essential

75 NEW 13501803

Drug Eluting Coronary Stent, 4.0 mm diameter,16-18mm length,sterile.

NOS C 4 E added NEW as essential

76 NEW 13501804

Drug Eluting Coronary Stent, 4.0 mm diameter,19-21mm length,sterile.

NOS C 4 E added NEW as essential

77 NEW 13501805

Drug Eluting Coronary Stent, 4.0 mm diameter,22-24mm length,sterile.

NOS C 4 E added NEW as essential

78 NEW 13501806

Drug Eluting Coronary Stent, 4.0 mm diameter,25-27mm length,sterile.

NOS C 4 E added NEW as essential

79 NEW 13501807

Drug Eluting Coronary Stent, 4.0 mm diameter,28-30mm length,sterile.

NOS C 4 E added NEW as essential

80 NEW 13501808

Drug Eluting Coronary Stent, 4.0 mm diameter,31-33mm length,sterile.

NOS C 4 E added NEW as essential

81 NEW 13501420

Covered Coronary Stent for Emergency use. NOS C 4 N added NEW as essential

82 NEW 13501419

Peripheral Stent for Emergency use. NOS C 4 N added NEW as essential

83 NEW 13501431

Coarctation Stent, CP Stent type.(Bare Metal & covered) for Emergency use.

NOS C 4 N added NEW as essential

DELETED ITEMS

1 13510405 Coronary Stent, bare metal, size 2.5mm diameter balloon, 19mm - 21mm length, premounted, sterile.

NOS C 4 E Deleted

2 13510608 Coronary Stent, bare metal, size 3.00mm diameter balloon, 29mm- 32mm length, premounted, sterile.

NOS C 4 E Deleted

Page 59: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

59 List 05

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

3 13501376 Coronary Stent, bare metal, size 4.00mm diameter balloon, 12mm- 14mm length, premounted, sterile.

NOS C 4 N Deleted

4 13501375 Coronary Stent, bare metal, size 4.00mm diameter balloon, 9mm/10mm length, premounted, sterile.

NOS C 4 N Deleted

5 13501407 Drug Eluting Coronary Stent, 2.5 mm diameter,assorted length,sterile.

NOS C 4 N Deleted

Page 60: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

60 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

CATHETER INTRODUCER SHEATHS/DEVICES DELIVERY SYSTEMS

1 13514200 Percutaneous Introducer Set, paediatric size, with side arm, haemostatic valve and guidewire, size 4F, 7cm - 7.5cm length, sterile.

NOS C 4 E continue

2 13514201 Percutaneous Introducer Set, paediatric size, with side arm, haemostatic valve and guidewire, size 5F, 7cm - 7.5cm length, sterile.

NOS C 4 E continue

3 13514202 Percutaneous Introducer Set, paediatric size, with side arm, haemostatic valve and guidewire, size 6F, 7cm - 7.5cm length, sterile.

NOS C 4 E continue

4 13514300 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 5F, 10cm (approx.) length, sterile.

NOS C 4 E continue

5 13514301 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 6F, 10cm (approx.) length, sterile.

NOS C 4 E continue

6 13514302 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 7F, 10cm (approx.) length, sterile.

NOS C 4 E continue

7 13514303 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 8F, 10cm (approx.) length, sterile.

NOS C 4 E continue

8 13514304 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 9F, 10cm (approx.) length, sterile.

NOS C 4 E continue

9 13514305 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 10F, 10cm (approx.) length, sterile.

NOS C 4 E continue

Page 61: ASD OCCLUSION DEVICES NO... · 2019. 6. 20. · ASD/PDA/VSD OCCLUSION DEVICES ASD OCCLUSION DEVICES 1 13515300 ASD Occlusion Device, Amplatzer type or similar, size 4mm, sterile

61 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

10 13514306 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 12F, 10cm (approx.) length, sterile.

NOS C 4 E continue

11 NEW

13514307

Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 14F, 10cm (approx.) length, sterile.

NOS C 4 E added NEW as essential

12 13514400 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 6F, 23cm (approx.) length, sterile.

NOS C 4 E continue

13 13514401 Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 7F, 23cm (approx.) length, sterile.

NOS C 4 E continue

14 NEW

13514402

Percutaneous Introducer Set, adult size, with side arm, haemostatic valve and guidewire, size 8F, 23cm (approx.) length, sterile.

NOS C 4 E added NEW as essential

15 13514500

Percutaneous Introducer Set, long sheath, Balkin type or similar, size 5.5F, 40cm - 60cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

16 13514501

Percutaneous Introducer Set, long sheath, Balkin type or similar, size 6F, 40cm - 60cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

17 13514502

Percutaneous Introducer Set, long sheath, Balkin type or similar, size 7F, 40cm - 60cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 E continue

18 13514503

Percutaneous Introducer Set, long sheath, Balkin type or similar, size 8F, 40cm - 60cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

19 13514600

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 6F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

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62 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

20 13514601

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 7F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 E specs amended

21 13514602

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 8F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 E specs amended

22 13514603

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 9F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 E specs amended

23 13514604

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 10F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 E specs amended

24 13514605

Delivery System for ASD device, with delivery cable, side arm, and haemostat valve, size 12F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 E specs amended

25 13514700

Delivery System for PDA device of ADO I type, with delivery cable, side arm, and haemostat valve, size 6F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

26 13514701

Delivery System for PDA device of ADO I type, with delivery cable, side arm, and haemostat valve, size 7F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

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63 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

27 13514702

Delivery System for PDA device of ADO I type, with delivery cable, side arm, and haemostat valve, size 8F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

28 13515100

Percutaneous Introducer Set, long sheath, hydrophyllic coated, Cook Flexor type or similar, size 4F, 90cm - 100cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

29 13515101

Percutaneous Introducer Set, long sheath, hydrophyllic coated, Cook Flexor type or similar, size 5F, 90cm - 100cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

30 13515102

Percutaneous Introducer Set, long sheath, hydrophyllic coated, Cook Flexor type or similar, size 6F, 90cm - 100cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

31 13515000

Percutaneous Introducer Set, long sheath, Cook Hausdorf Lock type or similar, size 10F, 70cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

32 13515001

Percutaneous Introducer Set, long sheath, Cook Hausdorf Lock type or similar, size 11F, 70cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

33 13515002

Percutaneous Introducer Set, long sheath, Cook Hausdorf Lock type or similar, size 12F, 70cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

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64 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

34 13514900

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 6F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

35 13514901

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 7F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

36 13514902

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 8F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

37 13514903

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 9F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

38 13514904

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 10F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

39 13514905

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 12F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

40 13514906

Percutaneous Introducer Set, long sheath, Mullin type or similar, size 14F, 60cm - 80cm length, should accept a guidewire of size 0.89mm (0.035") diameter or above, sterile.

NOS C 4 N continue

41 13514800

Delivery System for PDA device of ADO II type, with delivery cable, side arm, and haemostat valve, size 4F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

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65 List 06

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

42 13514801

Delivery System for PDA device of ADO II type, with delivery cable, side arm, and haemostat valve, size 5F, 80cm (approx.) length, with compatible should accept a guidewire of size 0.89mm (0.035") diameter or above,

NOS C 4 N specs amended

43 13515200 Delivery System for Detachable Embolization Coils, for Cook Flipper type coils, size 2.6F, 110cm (approx.) length, sterile.

NOS C 4 N continue

44 NEW

13508002

Tranceptal Sheath, Adult, Mullins type or similar, without side arm, size 7F, 60cm (approx.) length, should accept Medtronic type guidewire of size 0.81mm (0.032") diameter.

NOS C 4 N added NEW as essential

45 NEW

13508003

Tranceptal Sheath, Adult, Mullins type or similar, without side arm, size 8F, 60cm (approx.) length, should accept Medtronic type guidewire of size 0.81mm (0.032") diameter.

NOS C 4 N added NEW as essential

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66 List 07

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

OTHER ITEMS

1 13528900 Vascular Puncture Needle for angiography, size 18G cannula, 70mm (approx.) length, stainless steel, sterile.

NOS R 4 N continue

2 13528901 Vascular Puncture Needle for angiography, size 20G cannula, 40mm (approx.) length, stainless steel, sterile.

NOS R 4 E continue

3 13529000 Intra Venous Cannula without side port, Surflo type or similar, size 20G cannula, 32mmm (approx.) length, sterile.

NOS C 4 N continue

4 13529100 Intra Venous Cannula without side port, Surflo type or similar, size 18G cannula, 63mmm (approx.) length, sterile.

NOS R 4 N continue

5 13529001 Intra Venous Cannula without side port, Surflo type or similar, size 20G cannula, 50mmm (approx.) length, sterile.

NOS C 4 N continue

6 13529200 Myocardial Biopsy Forceps, flexible, Cook type or similar, size 3F, 120cm (approx.) length, sterile.

NOS C 4 N continue

7 13529202 Myocardial Biopsy Forceps, flexible, Cook type or similar, size 5.2F, 120cm (approx.) length, sterile.

NOS R 4 E continue

8 NEW

13529201

Myocardial Biopsy Forceps, flexible, Cordis type or similar, size 5F, 100cm - 120cm length, sterile.

NOS C 4 N added NEW as essential

9 NEW

13529203

Myocardial Biopsy Forceps, flexible, Cordis type or similar, size 6F, 100cm - 120cm length, sterile.

NOS C 4 N added NEW as essential

10 NEW

13529204

Myocardial Biopsy Forceps, flexible, Cordis type or similar, size 7F, 100cm - 120cm length, sterile.

NOS C 4 N added NEW as essential

11 13529300 Vascular Retrieval Forceps, flexible, Cook type or similar, size 3F, 120cm (approx.) length, sterile.

NOS C 4 N continue

12 13529400 Endovascular Snare, Amplatzer Goose neck type or similar, size 5mm, 120cm (approx.) length, with size 4F introducer, sterile.

NOS C 4 N continue

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67 List 07

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

13 13529401 Endovascular Snare, Amplatzer Goose neck type or similar, size 10mm, 120cm (approx.) length, with size 5F introducer, sterile.

NOS C 4 N continue

14 13529402 Endovascular Snare, Amplatzer Goose neck type or similar, size 15mm, 120cm (approx.) length, with size 6F introducer, sterile.

NOS C 4 N continue

15 13506800

Endovascular Snare, Andrasnare (Andra Medical) type or similar, size 5mm, 125cm (approx.) length, with size 4F introducer, sterile.

NOS C 4 N continue

16 13506801

Endovascular Snare, Andrasnare (Andra Medical) type or similar, size 10mm, 125cm (approx.) length, with size 5F introducer, sterile.

NOS C 4 N continue

17 13506802

Endovascular Snare, Andrasnare (Andra Medical) type or similar, size 15mm, 125cm (approx.) length, with size 6F introducer, sterile.

NOS C 4 N continue

18 NEW

13506803

Endovascular Snare, Andrasnare (Andra Medical) type or similar, size 20mm, 125cm (approx.) length, with size 7F introducer, sterile.

NOS C 4 N added NEW as essential

19 13529500

Endovascular Snare 3D, mini, EN (Merit Medical) snare type or similar, size 2mm - 4mm, 175cm (approx.) length, with size 4F introducer, sterile.

NOS C 4 N continue

20 13529501

Endovascular Snare 3D, mini, EN (Merit Medical) snare type or similar, size 4mm - 8mm, 175cm (approx.) length, with size 4F introducer, sterile.

NOS C 4 N continue

21 13529600

Endovascular Snare 3D, standard, EN (Merit Medical) snare type or similar, size 6mm - 10mm, 120cm (approx.) length, with size 6F introducer, sterile.

NOS C 4 N continue

22 13529601

Endovascular Snare 3D, standard, EN (Merit Medical) snare type or similar, size 9mm - 15mm, 120cm (approx.) length, with size 6F introducer, sterile.

NOS C 4 N continue

23 NEW

13529502

Endovascular Snare 3D, mini, large, EN (Merit Medical) snare type or similar, size 12mm - 20mm, 175cm (approx.) length, with size 7F introducer, sterile.

NOS added NEW as essential

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68 List 07

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

24 NEW

13529503

Endovascular Snare 3D, mini, large, EN (Merit Medical) snare type or similar, size 18mm - 30mm, 175cm (approx.) length, with size 7F introducer, sterile.

NOS added NEW as essential

25 13529700

Tubing for Contrast Injection, clear, braided and flexible polyurethane or similar material, rated pressure 1200 psi, 25cm - 50cm length, sterile.

NOS C 4 N specs modified

26 13529701

Tubing for Contrast Injection, clear, braided and flexible polyurethane or similar material, rated pressure 1200 psi, 55cm - 75cm length, sterile.

NOS C 4 N specs modified

27 13529702

Tubing for Contrast Injection, clear, braided and flexible polyurethane or similar material, rated pressure 1200 psi, 80cm - 100cm length, sterile.

NOS C 4 N specs modified

28 13529703

Tubing for Contrast Injection, clear, braided and flexible polyurethane or similar material, rated pressure 1200 psi, 105cm - 150cm length, sterile.

NOS C 4 N specs modified

29 13529800 Tubing for Contrast Injection, clear, medical grade PVC, rated pressure 1200 psi, 25cm - 50cm length, sterile.

NOS C 4 N specs modified

30 13529801 Tubing for Contrast Injection, clear, medical grade PVC, rated pressure 1200 psi, 55cm - 75cm length, sterile.

NOS C 4 N specs modified

31 13529802 Tubing for Contrast Injection, clear, medical grade PVC, rated pressure 1200 psi, 80cm - 100cm length, sterile.

NOS C 4 N specs modified

32 13529803 Tubing for Contrast Injection, clear, medical grade PVC, rated pressure 1200 psi, 105cm - 150cm length, sterile.

NOS C 4 N specs modified

33 NEW

13529804

Tubing for Contrast Injection, clear, medical grade PVC, rated pressure 1200 psi, 200cm (approx.) length, sterile.

NOS added NEW as essential

34 13529900 Tubing for Pressure Monitoring, clear, non expanding, medical grade PVC, 25cm - 50cm length, sterile.

NOS C 4 N continue

35 13529901 Tubing for Pressure Monitoring, clear, non expanding, medical grade PVC, 55cm - 75cm length, sterile.

NOS C 4 N continue

36 13529902 Tubing for Pressure Monitoring, clear, non expanding, medical grade PVC, 80cm - 100cm length, sterile.

NOS C 4 N continue

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69 List 07

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

37 13529903 Tubing for Pressure Monitoring, clear, non expanding, medical grade PVC, 105cm - 150cm length, sterile.

NOS C 4 N continue

38 NEW

13529904

Tubing for Pressure Monitoring, clear, non expanding, medical grade PVC, 200cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

39 14102101

Arterial lines for direct arterial pressure monitoring. Conforming to ISO standards, Seldinger technique, cannula size 20G, 8cm (approx) length, luer lock fitting, sterile.

NOS R 1 E Revised by Anaes. FR Sub Com.

40 14102102

Arterial lines for direct arterial pressure monitoring. Conforming to ISO standards, Seldinger technique, cannula size 21G, 4cm - 6cm length, luer lock fitting, sterile.

NOS R 1 N Revised by Anaes. FR Sub Com.

41 13530000 Pressure Injector Syringe, compatible with Angiomat Illumina Injector Pump, 150ml, sterile.

NOS C 4 N continue

42 13530200 Y - Adapter with Touhy - Borst valve, with side arm, sterile.

NOS C 4 E continue

43 13530100 Inflation Device for PTCA, with 20ml - 25ml syringe capacity.

NOS C 4 E continue

44 13530700 Coronary Manifold, Three Port Manifold, high pressure, with rotating adapter, sterile.

NOS C 4 N specs modified

45 13530300 Three Way Adaptor, high pressure, sterile. NOS C 4 E continue

46 13530500 Hemostasis Valve, with sideport tubing and 3-way stopcock.

NOS C 4 N continue

47 13530600 Torque Device, for 0.25mm - 0.51mm (0.010"- 0.020") diameter wires.

NOS C 4 N continue

48 13530800 Torque Device, for 0.53mm - 1.02mm (0.021" - 0.040") diameter wires.

NOS C 4 N continue

49 13590001 Angiographic syringe, with rotatable luer, 10cc - 12cc, sterile. with reservoir.Sterile.Packed individually and labelled accordingly.

NOS C 4 E specs modified & reintroduced

50 13530400 Introducer for coronory guidewires, sterile. NOS C 4 N continue

51 12000101 Prejelled E.C.G. Electrodes Silver/Silver Chloride for Adult Disposable. Each set packed individually and labelled accordingly.

NOS R 1 E specs modified

52 New

13590101 Connecting cable for Radiofrequency ablator, Baylis type or similar.

NOS C 4 N

added NEW as essential

53 New

13590102 Radiofrequency Wire for Radiofrequency ablator, Nykanen type or similar.

NOS C 4 N

added NEW as essential

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70 List 07

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

54 New

13590103 Microcatheter for Radiofrequency ablator, ProTrack type or similar.

NOS C 4 N

added NEW as essential

55 NEW Trasseptal Puncture Needle 71cm BRK-1 type or similar.

NOS C 4 N

Available as 13600300

56 NEW

13590301 Pressure wire Cetrtus Agile tip type or similar, size 0.14"- 175cm.

NOS C 4 N

added NEW as essential

57 NEW

13590201

Intravascular Ultrasound(IVUS) catheter, Opticross 40 MH3 Coronary Imagine catheter-3.0Fx135cm.

NOS C 4

N

added NEW as essential

58 NEW

13590401 Disposable Pullback Sled for motordrive. NOS C 4

N

added NEW as essential

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71 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

RECOMMENDATION OF SUB COMM

GUIDE WIRES

1 13523900 Coronary Guidewire, Balance Middle Weight (BMW) type or similar, J tip, size 0.36mm (0.014") diameter, 260cm - 300cm (approx.) length, sterile.

NOS C 4 N specs amended

2 13523901 Coronary Guidewire, Balance Middle Weight (BMW) type or similar, straight tip, size 0.36mm (0.014") diameter, 260cm - 300cm (approx.) length, sterile.

NOS C 4 N specs amended

3 NEW

13523902

Coronary Guidewire, Balance Middle Weight (BMW) type or similar, J tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

4 NEW

13523903

Coronary Guidewire, Balance Middle Weight (BMW) type or similar, straight tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

5 13525601 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.53mm (0.021") diameter, 150cm - 190cm length, sterile.

NOS C 4 N specs amended

6 13525900 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.64mm (0.025") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

7 13526200 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.81mm (0.032") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

8 13526500 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.89mm (0.035") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

9 13526800 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.97mm (0.038") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

10 13525602 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.53mm (0.021") diameter, 260cm - 300cm length, sterile.

NOS C 4 N specs amended

11 13525901 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.64mm (0.025") diameter, 260cm - 300cm length, sterile.

NOS C 4 N specs amended

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72 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

12 13526201 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.81mm (0.032") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

13 13526501 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

14 13526801 Guidewire, straight tip, stainless steel core, PTFE (similar to Teflon) coated size 0.97mm (0.038") diameter, 260cm - 300cm length, sterile.

NOS C 4 N specs amended

15 13525500 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.53mm (0.021") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

16 13525800 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.64mm (0.025") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

17 13526100 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.81mm (0.032") diameter, 150cm - 190cm length, sterile.

NOS C 4 N specs amended

18 13526400 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.89mm (0.035") diameter, 150cm - 190cm length, sterile.

NOS C 4 N specs amended

19 13526700 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.97mm (0.038") diameter, 150cm - 190cm length, sterile.

NOS C 4 E specs amended

20 13525501 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.53mm (0.021") diameter, 260cm - 300cm length, sterile.

NOS C 4 N specs amended

21 13525801 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.64mm (0.025") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

22 13526101 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.81mm (0.032") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

23 13526401 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

24 13526701 Guidewire, J tip, stainless steel core, PTFE (similar to Teflon) coated size 0.97mm (0.038") diameter, 260cm - 300cm length, sterile.

NOS C 4 E specs amended

25 13524300

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.46mm (0.018") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

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73 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

26 13524500

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.53mm (0.021") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

27 13524700

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.64mm (0.025") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

28 13524900

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.81mm (0.032") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

29 13525100

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.89mm (0.035") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

30 13525300

Guidewire, straight tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.97mm (0.038") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

31 13524301

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.46mm (0.018") diameter, 260cm - 300cm length, sterile.

NOS C 4 N continue

32 13525700

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.53mm (0.021") diameter, 260cm - 300cm length, sterile.

NOS C 4 N continue

33 13526000

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.64mm (0.025") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

34 13524901

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.81mm (0.032") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

35 13526600

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

36 13526900

Guidewire, straight, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.97mm (0.038") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

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74 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

37 13524200

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.46mm (0.018") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

38 13524400

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.53mm (0.021") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

39 13524600

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.64mm (0.025") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

40 13524800

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.81mm (0.032") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

41 13525000

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.89mm (0.035") diameter, 150cm - 190cm length, sterile.

NOS C 4 N continue

42 13525200

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.97mm (0.038") diameter, 150cm - 190cm length, sterile.

NOS C 4 E continue

43 13524201

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.46mm (0.018") diameter, 260cm - 300cm length, sterile.

NOS C 4 N continue

44 13524401

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.53mm (0.021") diameter,260cm - 300cm length, sterile.

NOS C 4 N continue

45 13524601

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.64mm (0.025") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

46 13524801

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.81mm (0.032") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

47 13525001

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.89mm (0.035") diameter,260cm - 300cm length, sterile.

NOS C 4 E continue

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75 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

48 13525201

Guidewire, J tip, Nitinol core, hydrophilic coated, Terumo guidewire M type or similar, size 0.97mm (0.038") diameter, 260cm - 300cm length, sterile.

NOS C 4 E continue

49 13524000

Guidewire, J tip, Amplatzer Super Stiff type or similar, stainless steel core, PTFE coated, size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 N continue

50 13524001

Guidewire, J tip, Amplatzer Super Stiff type or similar, stainless steel core, PTFE coated, size 0.97mm (0.038") diameter, 260cm - 300cm length, sterile.

NOS C 4 N continue

51 NEW

13524101 Amplatzer Guidewire-Fixed Noodlewire 0.035"x300cm.

NOS C 4 N added NEW as essential

52 NEW

13524102 Hi Torque WIGGLE Guide wire 190cm. NOS C 4 N

added NEW as essential

53 NEW

13524103 Rosen Curved Guidewire 0.035"x260cm length. NOS C 4 N

added NEW as essential

54 NEW

13527001

Coronary Guidewire, Similar to Roadrunner Extra support, straight tip, size 0.46mm (0.018") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

55 NEW

13527002

Coronary Guidewire, Similar to Roadrunner Extra support, straight tip, size 0.46mm (0.018") diameter, 300cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

56 NEW

13525401

Coronary Guidewire, Similar to Asahi Sion Blue, J tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

57 NEW

13525402

Coronary Guidewire, Similar to Asahi Sion Blue, straight tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

58 NEW

13525403

Coronary Guidewire, Similar to Asahi Sion , J tip, size 0.36mm (0.014") diameter, 0.7 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

59 NEW

13525404

Coronary Guidewire, Similar to Asahi Sion, straight tip, size 0.36mm (0.014") diameter, 0.7 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

60 NEW

13525405

Coronary Guidewire, Similar to Asahi Sion Black , J tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

61 NEW

13525406

Coronary Guidewire, Similar to Asahi Sion Black, straight tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

62 NEW

13527003

Coronary Guidewire, Similar to Rinato, J tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

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76 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

63 NEW

13527004

Coronary Guidewire, Similar to Route, straight tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

64 NEW

13527101

Coronary Guidewire, Similar to Gaia first , J tip, size 0.36mm (0.014") diameter, 1.7 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

65 NEW

13527102

Coronary Guidewire, Similar to Gaia first, straight tip, size 0.36mm (0.014") diameter, 1.7 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

66 NEW

13527103

Coronary Guidewire, Similar to Gaia second , J tip, size 0.36mm (0.014") diameter, 3.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

67 NEW

13527104

Coronary Guidewire, Similar to Gaia second, straight tip, size 0.36mm (0.014") diameter, 3.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

68 NEW

13527105

Coronary Guidewire, Similar to Gaia third , J tip, size 0.36mm (0.014") diameter, 4.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

69 NEW

13527106

Coronary Guidewire, Similar to Gaia third, straight tip, size 0.36mm (0.014") diameter, 4.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

70 NEW

13528801

Coronary Guidewire, Similar to Fielder XT - R , J tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

71 NEW

13528802

Coronary Guidewire, Similar to Fielder XT- R, straight tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

72 NEW

13528803

Coronary Guidewire, Similar to Fielder XT - A , J tip, size 0.36mm (0.014") diameter, 1.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

73 NEW

13528804

Coronary Guidewire, Similar to Fielder XT - A, straight tip, size 0.36mm (0.014") diameter, 1.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

74 NEW

13528805

Coronary Guidewire, Similar to Fielder FC , J tip, size 0.36mm (0.014") diameter, 1.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

75 NEW

13528806

Coronary Guidewire, Similar to Fielder FC, straight tip, size 0.36mm (0.014") diameter, 0.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

76 NEW

13528807

Coronary Guidewire, Similar to Fielder, J tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

77 NEW

13528808

Coronary Guidewire, Similar to Fielder, straight tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

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77 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

78 NEW

13528809

Coronary Guidewire, Similar to Grand Slam, J tip, size 0.36mm (0.014") diameter, 0.8 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

79 NEW

13528810

Coronary Guidewire, Similar to Grand Slam, straight tip, size 0.36mm (0.014") diameter, 0.7 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

80 13527202 Coronary Guidewire, Similar to Intermediate, J tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 E specs amended

81 13527400 Coronary Guidewire, Similar to Intermediate, straight tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 E specs amended

82 NEW

13527401

Coronary Guidewire, Similar to Ulimate, J tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

83 NEW

13527402

Coronary Guidewire, Similar to Ultimate, straight tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

84 13527900 Coronary Guidewire, Similar to Miracle 3, J tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

85 13527800 Coronary Guidewire, Similar to Miracle 3, straight tip, size 0.36mm (0.014") diameter, 3.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

86 13528100 Coronary Guidewire, Similar to Miracle 4.5, J tip, size 0.36mm (0.014") diameter, 4.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

87 13528000 Coronary Guidewire, Similar to Miracle 4.5, straight tip, size 0.36mm (0.014") diameter, 4.5 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

88 13528300 Coronary Guidewire, Similar to Miracle 6, J tip, size 0.36mm (0.014") diameter, 6.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

89 13528200 Coronary Guidewire, Similar to Miracle 6, straight tip, size 0.36mm (0.014") diameter, 6.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

90 13528700 Coronary Guidewire, Similar to Miracle 12, J tip, size 0.36mm (0.014") diameter, 12 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

91 13528600 Coronary Guidewire, Similar to Miracle 12, straight tip, size 0.36mm (0.014") diameter, 12 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

92 13528500 Coronary Guidewire, Similar to Conquest, J tip, size 0.36mm (0.014") diameter, 9.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

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78 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

93 13528400 Coronary Guidewire, Similar to Conquest, straight tip, size 0.36mm (0.014") diameter, 9.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N specs amended

94 NEW

13528401

Coronary Guidewire, Similar to Conquest Pro, J tip, size 0.36mm (0.014") diameter, 9.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

95 NEW

13528402

Coronary Guidewire, Similar to Conquest Pro, straight tip, size 0.36mm (0.014") diameter, 9.0 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

96 NEW

13528403

Coronary Guidewire, Similar to Conquest Pro 12, J tip, size 0.36mm (0.014") diameter, 12 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

97 NEW

13528404

Coronary Guidewire, Similar to Conquest Pro 12, straight tip, size 0.36mm (0.014") diameter, 12 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

98 NEW

13528405

Coronary Guidewire, Similar to Conquest Pro 8 - 12, J tip, size 0.36mm (0.014") diameter, 20 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

99 NEW

13528406

Coronary Guidewire, Similar to Conquest Pro 8 - 12, straight tip, size 0.36mm (0.014") diameter, 20 tip load, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

100 NEW

13527601

Coronary Guidewire, Similar to Extra support, J tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

101 13527600 Coronary Guidewire, Similar to Extra support, straight tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 E specs amended

102 NEW

13527602

Coronary Guidewire, Similar to Extra support, J tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

103 NEW

13527603

Coronary Guidewire, Similar to Extra support, straight tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

104 13527200 Coronary Guidewire, Similar to Choice Floppy, J tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 E specs amended

105 13527300 Coronary Guidewire, Similar to Choice Floppy, straight tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 E specs amended

106 13527201 Coronary Guidewire, Similar to Choice Floppy, J tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 E specs amended

107 13527301 Coronary Guidewire, Similar to Choice Floppy, straight tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 N specs amended

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79 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

108 NEW

13527702

Coronary Guidewire, Similar to Pilot 50, J tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

109 NEW

13527703

Coronary Guidewire, Similar to Pilot 50, straight tip, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N added NEW as essential

110 NEW

13527704

Coronary Guidewire, Similar to Pilot 50, J tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

111 NEW

13527705

Coronary Guidewire, Similar to Pilot 50, straight tip, size 0.36mm (0.014") diameter, 300cm (approx.) length, sterile.

NOS C 4 N added NEW as essential

112 NEW

13525407

Coronary Guidewire, Similar to Asahi Extension wire, straight tip, size 0.36mm (0.014") diameter, 150cm - 165cm length, sterile.

NOS C 4 N added NEW as essential

DELETED ITEMS

1 13527700

Guidewire for Percutaneous Transluminal Coronary Angioplasty (PTCA), special type, Fielder FC type or similar, hydrophilic coated, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N

2 13527701

Guidewire for Percutaneous Transluminal Coronary Angioplasty (PTCA), special type, Fielder XT type or similar, hydrophilic coated, size 0.36mm (0.014") diameter, 175cm - 190cm length, sterile.

NOS C 4 N

3 13524100

Guidewire, angled tip, Amplatzer Stiff type or similar, stainless steel core, PTFE coated, size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 N

4 13525400 Guidewire, angled tip, Nitinol core, hydrophilic coated, size 0.89mm (0.035") diameter, 260cm - 300cm length, sterile.

NOS C 4 N

5 13525600 Guidewire, straight tip, stainless steel core, PTFE coated size 0.53mm (0.021") diameter, 45cm - 50cm length, sterile.

NOS C 4 N

6 13527000 Guidewire, straight tip, stainless steel core, PTFE coated size 0.97mm (0.038") diameter, 45cm - 50cm length, sterile.

NOS C 4 N

7 13528800 Guidewire, J tip, stainless steel core, PTFE coated size 0.53mm (0.021") diameter, 45cm - 50cm length, sterile.

NOS C 4 N

8 13526702 Guidewire, J tip, stainless steel core, PTFE coated size 0.97mm (0.038") diameter, 45cm - 50cm (approx.) length, sterile.

NOS C 4 N

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80 List 08

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

9 13527100 Guidewire, angled tip, stainless steel core, hydrophilic coated size 0.53mm (0.021") diameter, 45cm - 50cm length, sterile.

NOS C 4 N

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81 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

NO: SRNO SPEC_CONCAT

UN

IT O

F M

EASU

RE

CO

MP

_REG

ITEM

_LEV

EL

VEN

SUB COM DECISION

GROUP NO 136 - PACEMAKERS & ELECTROPHYSIOLOGY CONSUMABLE ITEMS

1 13603800

Permenant Pacemaker, Dual Chamber, rate responsive (DDDR) mode, multiprogrammable with alogorithm to reduce ventricular pacing and end life indicator with manufacturer's guarantee of pacemaker life (minimum 10 years), including compatible IS1 active fixation leads (52 -63 cm - atrial & ventricular) and lead introducer sets with sheaths. Should include a pacemaker programmer with analyzer for every 200 devices and compatible set of analyzer cables for every 25 devices.

NOS C 4 N specifications revised

2 13603701

Permenant Pacemaker, Paediatric, Single Chamber, rate responsive, SSIR mode, multiprogrammable, with end life indicator and manufacturer's guarantee of pacemaker battery life (minimum 7 years), including compatible active fixation, IS1 (46 -52 cm) lead and lead introducer set with sheath. Should include a pacemaker programmer with analyzer for every 200 devices and compatible set of analyzer cables for every 50 devices.

NOS C 4 E specifications revised

3 13603700

Permenant Pacemaker, Single Chamber, rate responsive, SSIR mode, multiprogrammable, with end life indicator and manufacturer's guarantee of pacemaker battery life (minimum 10 years), including compatible active fixation IS1 lead (58 - 63 cm) and lead introducer set with sheath. Should include a pacemaker programmer with analyzer for every 200 devices and compatible set of analyzer cables for every 50 devices

NOS C 4 N specifications revised

4 13604200

Implantable Cardioverter Defibrillator (ICD), Dual Chamber, multiprogrammable,with end life indicator and manufacturer's guarantee of device battery life (minimum 5 years or 200 shocks). Should inlcude Single coil ICD lead with DF4 connector and IS1 atrial lead with compatible intrioducer sets with sheaths. A compatible device programmer should be provided with every 10 sets of devices.

NOS C 4 N specifications revised

5 13604100

Implantable Cardioverter Defibrillator (ICD), Single Chamber, multiprogrammable,with end life indicator and manufacturer's guarantee of device battery life (minimum 5 years or 200 shocks). Should inlcude Single coil ICD lead with DF4 connetor and compatible intrioducer set with sheath. A compatible device programmer should be provided with every 10 sets of devices.

NOS C 4 E specifications revised

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82 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

6 13603900

Permenant Pacemaker, Biventricular, for Cardiac Resyncronization Therapy (CRT), Dual Chamber, rate responsive, DDDR mode, multiprogrammable, with end life indicator and manufacturer's guarantee of pacemaker life, (minimum 7 years). Should inlcude compatible active fixation atrial & right ventricular IS1 leads, over the wire left ventricular lead and a compatible backup epicardial lead. Atrial and RV leads should be provided with compatible introducer sets and sheaths. LV lead should be provided with TWO Nos. compatible sheaths and introducer set. A compatible analyser system with analyzer cables for every 10 devices.

NOS C 4 E specifications revised

7 13604000

Permenant Pacemaker, for neurocardiogenic syncope, Dual Chamber, rate responsive, DDDR mode with Rate Drop Response or Closed loop stimulation protocol, multiprogrammable, with end life indicator and manufacturer's guarantee of pacemaker life, (minimum 7 years), including compatible IS1 active fixation leads (atrial & ventricular) and lead introducer sets with shearths.

NOS C 4 N specifications revised

8 NEW

13604501

Leadless pacemaker (VVIR mode, multiprogrammble with detacheble fixation mechanism and guaranteed battery life of 8 years) with compatible implantation kit and accessories.

NOS C 4 N NEW ITEM AS ESSENTIAL

9 13604400

Implantable Loop Recorder, multiprogrammable, with manufacturer gurateed battery life not less than 1 year along with implantation kit. A compatible analyzer with every 20 devices.

NOS C 4 N specifications revised

10 NEW

13604601

Portable Temporary pulse generator (TPM) . Single chamber with programmable output, rate and capability for burst pacing. Should be provided with reusable arm / limb strap

NOS C 4 N NEW ITEM AS ESSENTIAL

11 13600900 Temporary Pacemaker Electrode Catheter, Bipolar, for adult, with venous introducer kit, size 6F, sterile.

NOS C 4 E continue

12 13600800 Temporary Pacemaker Electrode Catheter, Bipolar, for paediatric, with venous introducer kit, size 4F, sterile.

NOS C 4 N continue

13 13600801 Temporary Pacemaker Electrode Catheter, Bipolar, for paediatric, with venous introducer kit, size 5F, sterile.

NOS C 4 E continue

14 13601600

Ablation Catheter, with medium curve, size 7F - 7.5F, standard length, distal tip 4mm, irrigated tip, sterile. Provided with fluid conduit accessory for irrigation pump

NOS C 4 N specifications amended

15 13601500

Ablation Catheter, with large curve, size 7F - 7.5F, standard length, distal tip 4mm, irrigated tip, sterile. Provided with fluid conduit accessory for irrigation pump

NOS C 4 N specifications amended

16 13601401

Ablation Catheter, with small curve, size 7F - 7.5F, standard length, distal tip 4mm, irrigated tip, sterile. Provided with fluid conduit accessory for irrigation pump

NOS C 4 N specifications amended

17 13601300 Ablation Catheter, with small curve, size 5F, standard length, distal tip 4mm, sterile.

NOS C 4 N specifications amended

18 13601100 Ablation Catheter, with small curve, size 7F, standard length, distal tip 4mm, bi - directional movement, sterile.

NOS C 4 N specifications amended

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83 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

19 13601301 Ablation Catheter, with medium curve , paediatric, size 5F, standard length, distal tip 4mm, sterile.

NOS C 4 N specifications amended

20 13601101 Ablation Catheter, with medium curve, size 7F, standard length, distal tip 4mm, bi - directional movement, sterile.

NOS C 4 N specifications amended

21 13601302 Ablation Catheter, with large curve , paediatric, size 5F, standard length, distal tip 4mm, sterile.

NOS C 4 N specifications amended

22 13601102 Ablation Catheter, with large curve, size 7F, standard length, distal tip 4mm, bi - directional movement, sterile.

NOS C 4 N specifications amended

23 13601200 Ablation Catheter, with small curve , size 7F, standard length, distal tip 8mm, bi - directional movement, sterile.

NOS C 4 N specifications amended

24 13601201 Ablation Catheter, with large curve , size 7F, standard length, distal tip 8mm, bi - directional movement, sterile.

NOS C 4 N specifications amended

25 13603300 Compatible connecting cable for atrial mapping catheter.

NOS C 4 E specifications amended

26 13602700 Compatible Connecting Cable for ablation catheter, length 210cm - 300cm.

NOS C 4 E specifications amended

27 13602900 Compatible Connecting Cable, for Irrigated tip ablation catheter.

NOS C 4 N specifications amended

28 NEW

13602901 Irrigation Pump compatible with irrigated tip catheters NOS C 4 N

NEW ITEM AS ESSENTIAL

29 13603500 Compatible Connecting Cable, for electrode mesh catheter for pulmonary vein mapping.

NOS C 4 N continue

30 13603400 Compatible Connecting Cable, for pulmonary vein mapping catheters.

NOS C 4 N specifications amended

31 13603201 Compatible Connecting Cable, for deflectable deca polar catheter.

NOS C 4 E specifications amended

32 13603200 Compatible Connecting Cable, for deflectable quad polar catheter.

NOS C 4 E specifications amended

33 13603000 Compatible Connecting Cable, for Josephson quadpolar catheter.

NOS C 4 E specifications amended

34 13603100 Compatible Connecting Cable, for size 4F/6F Damato catheter.

NOS C 4 E specifications amended

35 13602300 Diagnostic Catheter, 16 - 20 polar, for atrial mapping, size 7F, 2 - 5 - 2 mm electrode spacing, standard length, sterile.

NOS C 4 E continue

36 13602001 Diagnostic Catheter, deca polar, deflectable large sweep, size 6F, 2 - 5 - 2 mm electrode spacing, standard length, sterile.

NOS C 4 N continue

37 13602000 Diagnostic Catheter, deca polar, deflectable medium sweep, size 6F, 2 - 5 - 2 mm electrode spacing, standard length, sterile.

NOS C 4 N continue

38 13602400 Diagnostic Catheter (lasso type), for pulmonary vein mapping, size 6F, sterile.

NOS C 4 E continue

39 13601801 Diagnostic Catheter, quadpolar, Damato type or similar, size 4F, standard length, sterile

NOS C 4 E continue

40 13601800 Diagnostic Catheter, quadpolar, Damato type or similar, size 6F, standard length, sterile

NOS C 4 E continue

41 13601900 Diagnostic Catheter, quadpolar, deflectable type, size 6F, 2 - 5 - 2 mm electrode spacing, standard length, sterile.

NOS C 4 E continue

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84 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

42 13601701 Diagnostic Catheter, quadpolar, Josephson type or similar, size 4F, standard length, sterile

NOS C 4 E continue

43 13601700 Diagnostic Catheter, quadpolar, Josephson type or similar, size 6F, standard length, sterile

NOS C 4 E continue

44 13603600 Grounding Pad for ablation therapy NOS C 4 N continue

45 13600400 Introducer Sheath for adult size transeptal needle, size 8F, 60cm - 80cm length, with side arm, haemostatic valve and compatible guidewire, sterile.

NOS C 4 N continue

46 13600401 Introducer Sheath for paediatric size transeptal needle, size 7F, 50cm - 70cm length, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

47 13600000

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SL 0 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

48 13600001

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SL 1 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

49 13600002

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SL 2 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

50 13600100

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SR 0 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

51 13600101

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SR 1 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

52 13600102

Percutaneous Introducer Set, with a long sheath of 40cm - 60cm, size 8F, SR 2 type or similar, with side arm, haemostat valve and compatible guidewire, sterile.

NOS C 4 N continue

53 13600700 Percutaneous Introducer Sheath, peel awy type, size 5F, 7.0 cm - 7.5cm length, sterile.

NOS C 4 E continue

54 13600701 Percutaneous Introducer Sheath, peel awy type, size 6F, 10cm (approx.) length, sterile.

NOS C 4 E continue

55 13600300 Transeptal Needle, adult, Brockenbrough type or similar, size 18G, 70cm - 80cm length, stainless steel, sterile.

NOS C 4 E continue

56 13600301 Transeptal Needle, paediatric, Brockenbrough type or similar, size 19G, 50cm - 60cm length, stainless steel, sterile.

NOS C 4 E continue

57 13605011 Vascular sheath complete set with introducer and guide wires size 6F, sterile.

NOS C 4 N specifications amended & re-introduced

58 13605012 Vascular sheath complete set with introducer and guide wires size 7F, sterile.

NOS C 4 N specifications amended & re-introduced

59 13605013 Vascular sheath complete set with introducer and guide wires size 8F sterile.

NOS C 4 N specifications amended & re-introduced

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85 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

60 13650002 Debibrillation gel pads NOS C 4 N specifications amended & re-introduced

61 NEW

13650003 Self adhesive pads for defibrillator with compatible connector

NOS C 4 N NEW ITEM AS ESSENTIAL

62 NEW

13650101 Electromagnetic Patches for NavX 3D mapping system with compatible connector cables

NOS C 4 N

Added as new item compatible with NavX 3D machine.

ITEMS DELETED AT 2011 REVISION

1 13605014

Compatiable leads for dual chamber pacemaker for neurocardiogenic syncope.Active fixation 58cm straight leads,bipolar steroid eluting, standard size 9F or less,length 50cm to 58cm mixed range.Sterile,Packed individually and labelled accordingly.

NOS 4 N DELETE

2 13605015

Compatible leads for dual chamber pacemaker for neurocardiogenic syncope,bipolar steroid eluting, standard size 9F or less,length 50 to 58cm mixed range,ventricular,Active fixation.Sterile,packed individually and labelled accordingly.

NOS 4 N DELETE

3 13605016

Biventricular pacemaker DDDR for re-synchronization therapy with dual slope rate response profile,multiple modes of pacing,ability for A-V synchronization,event counter facility,circadain rhythem adjestment.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

4 13605017

Lead system(proximal and distal) for biventricular pacemaker DDDR for re-synchronization therapy with coronary sinus lead with over the wire technique,guiding catheter and accessories for lead placement,fixing wire etc.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

5 13605018

Transvenous Flanged or Self - retaining Atrial Leads , Bipolar, with ISI connection, matchng for DD - DDD Multiprogrammable Permenant Pacemaker, sterile. Each atrial lead packed individually and labelled accordingly.

NOS 4 N DELETE

6 13605019 Programmer for DDD/DDDR Multiprogrammable Permanant Pacemaker.Packed individually and labelled accordingly.

NOS 4 N DELETE

7 13605020 Programer / Analyser for DDD Bipolar Pacemaker.Packed individually and labelled accordingly.

NOS 4 N DELETE

8 13605021

Transvenous Flanged or Self - retaining Electrodes, Bipolar, matchng for V V I/VVIR Paediatric Pacemaker(Ventricular,bipolar steroid eluting standered self fixation size 8F or less.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

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86 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

9 13605022

Guiding introducer sheath with hemostatis valve and side port,dilatator145cm guide wire with finger stralghtenable 3mm , 50 digree "J" curved SR0, 8F,63cm sheath length,0.038" guide wire.Sterile.Packed individually and lable accordingly.

NOS 4 N DELETE

10 13605023

Guiding introducer sheath with hemostatis valve and side port,dilatator 145cm guide wire with finger straightenable 3mm , 45 digree "J" curved, SR1,8F,63cm sheath length,0.038" guide wire.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

11 13605024

Guiding introducer sheath with hemostatis valve and side port,dilatator 145cm guide wire with finger straightenable 3mm,90 digree "J" curved, SR2,8F,63cm sheath length,0.038" guide wire.Sterile.Packed individuallly and labelled accordingly.

NOS 4 N DELETE

12 13605025

Transvenous Flanged or Self - retaining Ventricular Leads , Bipolar, with ISI connection, matchng for DD - DDD Multiprogrammable Permenant Pacemaker, sterile. Each ventricular lead packed individually and labelled accordingly.

NOS 4 N DELETE

13 13605026

DDD/DDDR Bipolar Pacemakers with multiple diagnostics including lifetime lead impedence monitor, 24 hour rate trend full mode programmability including V V I R, A A I R and V D D mode switch, matching 7F bipolar steroid eluting lead and lifetime warranty, sterile. Each pacemaker packed individually and labelled accordingly.

NOS 4 N DELETE

14 13605027 Lead system for DDDR biventricular pace maker(set).Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

15 13605028

Guiding introducer sheath with heamostatis valve and side port,dialator 145cm guide wire with finger straightenable 3mm,45 digree "J" curved,SL1,63cm sheath length,0.038" guide wire.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

16 13605030 Trans-septal sheath with side arm and valve.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

17 13605031 Defibrilltor shocking pads NOS 4 N DELETE

18 13605032

Ventricular leads,self fixation(bipolar steroid eluting standard size 9F or less) length 50 to 58cm mixed range for VVIR permanant pacemaker.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

19 13605034 Epicardial leads for pemanent pacing. Sterile. Packed individually and labelled accordingly.

NOS 4 N DELETE

20 13605035 Guide wires compatible with transeptal sheath size 0.32".Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

21 13605036 Quadpolar cath 6F/110cm NOS 4 N DELETE

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87 List 09

SCO(QA 1):………………………… AD(QA):……………………… Director/MSD:………………………..

22 13605037

Permanent Pacemaker multiprogrammable Mode VDD heart rate hysteresis pulse with amplitude polarity Longevity- Nominal amplitude with 100% paced minium 9 years Sterile Manufactures gurantee Technical support on request packed individually and labelled acordingly.

NOS 4 N DELETE

23 13605038

Cournard Decapolar diagnostic catheter curve type size 6F 110-125cm length,catheter made of WOVEN material with braided conducting wire Radiopaque & Antithrombogenic coating catheter should have bioflexibility over long period of timeSterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

24 13605039

Cournard Decapolar diagnostic catheter size 4F 110-125cm length,catheter made of WOVEN material with braided conducting wire Radiopaque & Antithrombogenic coating catheter should have bioflexibility and to maintain the stability over long period of time.

NOS 4 N DELETE

25 13605040

Small curve Decapolar diagnostic catheter curve type size 6F 110-125cm length,catheter made of WOVAN material with braided conducting wire Radiopaque & Antithrombogenic coating catheters should have bioflexibility and to maintain the stability ovwer long period packed individually and labell acordingly.

NOS 4 N DELETE

26 13605041 Compatible cables for Cournard Decapolar catheters.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

27 13605042 Diagnostic deflecting decapolar catheter 110cm,6FR push pull steering &rotating handle,2mm distal tip.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

28 13605043

Permanent Pacemaker VVIR with compatible lead and introducer sheath.Sterile.Packed individually and labelled accordingly.Patient ID card should be provided with each pacemaker.

SET 4 N DELETE

29 13601000 Pacemaker Lead Extraction System. NOS C 4 E DELETE

30 13605044 Ablation catheter with bi-directional flexion and rotational movements, Size 7F, packed individually and labeled accordingly.

NOS 4 N DELETE

31 13605045

Single chamber VVIR paediatric pacemakers with compatible 6F or 7F active fixation leads with introducer set, Packed individually and labeled accordingly.

NOS 4 N DELETE

32 13605046

Deflectable Decapolar catheter 6F 125cm length,with PUSH PULL STERING & ROTATING HANDLE and Distil TIP electrode 2mm.Sterile.Packed individually and labelled acordingly

NOS 4 N DELETE

33 13605047

Deflectable Quadpolar catheter size 4F,110/125cm length,with PUSH PULL STERING & ROTATING HANDLE and Distal tip electrode 2mm.Sterile.Packed individually and labelled accordingly.

NOS 4 N DELETE

34 13650001 Automated External Defibrillator NOS 4 N DELETE