ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

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Filters

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) (8) Catheter, Intravascular, Diagnostic (DQO) (2)

Premarket Exempt

No Yes

Clear

CRITICATH(TM) SP5327H MONITORING CATHETER - 00886333600588 Catalog Number : 680058

Device Description : Catheter 7FR, 2 Lumen, length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5337H MONITORING CATHETER - 00886333600595 Catalog Number : 680059

Device Description : Catheter 7FR, 3Lumen and length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507HS TD CATHETER - 00886333600625 Catalog Number : 680062

Device Description : Heparin coated Catheter of 7.5FR, 5 Lumen, Length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507S TD CATHETER - 00886333600632 Catalog Number : 680063

Device Description : Catheter of 7.5FR, 5 Lumen, with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507H TD CATHETER - 00886333600649 Catalog Number : 680064

Device Description : Heparin coated Catheter 7.5FR,5 Lumen with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507 TD CATHETER - 00886333600656 Catalog Number : 680065

Device Description : Catheter with 7.5FR, 5 Lumen, Tube length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507H-13 TD CATHETER - 00886333600663 Catalog Number : 680066

Device Description : Heparin coated Catheter with 7.5FR, 5 Lumen, Length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5507H-14 TD CATHETER - 00886333600670 Catalog Number : 680067

Device Description : Heparin coated catheter 7.5Fr, 5 Lumen with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5527H TD CATHETER - 00886333600700 Catalog Number : 680070

Device Description : Heparin coated catheter, 7.5Fr, 5 Lumen with length 110cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5537H PACING CATHETER - 00886333600717 Catalog Number : 680071

Device Description : Heparin coated Catheter 7.5 FR, 5 Lumen with length 110 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

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