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) (3) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (2) System, measurement, blood-pressure, non-invasive (DXN) (2) COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION (DXG) (1) Catheter, Intravascular, Diagnostic (DQO) (1) Catheter, intravascular, diagnostic (DQO) (1)

Premarket Exempt

No Yes

Clear

Merit Medical® - 00884450330999 Catalog Number : 684269/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Merit Medical® - 00884450331026 Catalog Number : 684272/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Merit Medical® - 00884450361016 Catalog Number : 684045/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : No

Device Count : 1

Merit Medical® - 00884450361023 Catalog Number : 684060/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : No

Device Count : 1

Merit Medical® - 00884450361030 Catalog Number : 684061/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : No

Device Count : 1

Merit Medical® - 00884450361054 Catalog Number : 684072/A

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DXG

Prescription Use : No

Device Count : 1

CRITIKIT(TM) SP4500 - 00886333600007 Catalog Number : 680000

Device Description : CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressu CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2 protective caps.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

CRITIKIT(TM) SP4572 - 00886333600021 Catalog Number : 680002

Device Description : Injectate delivery system includes a sensor housing with two-way check valve, a Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock protective covers.

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

SP5045 - 00886333600069 Catalog Number : 680006

Device Description : Single device, Injectate Housing SP5045

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

CRITICATH(TM) SP5105H TD CATHETER - 00886333600441 Catalog Number : 680044

Device Description : Heparin coated catheter 5FR,4Lumen, length 80 cm

Device Class : 2

Duns Number: 595138793

Premarket Exempt : No

Product Code : KRB

Prescription Use : Yes

Device Count : 1

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