ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Probe, Thermodilution (KRB) (6) Introducer, Catheter (DYB) (4)

Premarket Exempt

No Yes

Clear

CRITICATH(TM) SP5537H-13 PACING CATHETER - 00886333600724 Catalog Number : 680072

Device Description : Heparin coated Catheter7.5FR, 5 Lumen with length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5537H-14 PACING CATHETER - 00886333600731 Catalog Number : 680073

Device Description : Heparin coated Catheter7.5 FR, 5 Lumen with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH™ SP5107H + SP5045 TD CATHETER - 00886333600779 Catalog Number : 680077

Device Description : Heparin coated catheter, 7Fr, 4 Lumen with tube length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH™ SP5107H TD CATHETER - 00886333600786 Catalog Number : 680078

Device Description : Heparin coated catheter, 7Fr, 4 Lumen with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH™ SP5507H TD CATHETER - 00886333600823 Catalog Number : 680082

Device Description : Heparin Coated Catheter, 7.5Fr, 5 Lumen and tube length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH™ SP5107H-14 TD CATHETER - 00886333600885 Catalog Number : 680088

Device Description : Heparin coated catheter 7 Fr, 4 Lumen with tube 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

SHEATH INTRO POP KIT 6FR L5 MULT=5/50 - 00886333601226 Catalog Number : 680122

Device Description : Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x ID 1.90mm, guidewire 0.9x450mm, introducer 1.4x70mm and stopcock.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SHEATH INTRO 8.5FR L5 MULT=5/50 - 00886333601240 Catalog Number : 680124

Device Description : Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve O Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.53mm x ID 2.74mm x 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.7x70mm,1.4x70mm, Contamination Shield, stopcock, syringe, scalpel.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SHEATH INTRO KIT 8FR L5 MULT=5/50 - 00886333601264 Catalog Number : 680126

Device Description : Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve O Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.35mm x ID 2.51mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.7x70mm,1.4x70mm, Contamination Shield, stopcock, syringe, scalpel.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SHEATH INTRO KIT 6FR L5 MULT=5/50 - 00886333601288 Catalog Number : 680128

Device Description : Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x ID 1.90mm x 10cm and Dilator, guidewire 0.9x450mm, introducers 1.7x70mm 1.4x70mm, contamination shield, stopcock, syringe and scalpel.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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