RETIA MEDICAL, LLC

RETIA MEDICAL, LLC

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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

Computer, Diagnostic, Pre-Programmed, Single-Function (DXG) (10)

Premarket Exempt

No

Clear

Retia Medical - 00860001506402 Catalog Number :

Device Description : The Argos Cardiac Output monitoring device is intended for use on patients above The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506419 Catalog Number :

Device Description : Philips Interface Cable (3.5 mm Stereo Jack)

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506426 Catalog Number :

Device Description : GE Interface Cable (9-pin PDM)

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506433 Catalog Number :

Device Description : Transducer Interface Cable

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506440 Catalog Number :

Device Description : GE Interface Cable (7-pin Mini-DIN)

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506457 Catalog Number :

Device Description : Drager Interface Cable (14-pin MDR)

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506464 Catalog Number :

Device Description : Spacelabs Interface Cable

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506471 Catalog Number :

Device Description : Argos LAN Connectivity Kit

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506488 Catalog Number :

Device Description : Argos Serial Connectivity Kit

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

Retia Medical - 00860001506495 Catalog Number :

Device Description : Argos Monitor Power Supply and AC Cord

Device Class : 2

Duns Number: 025675871

Premarket Exempt : No

Product Code : DXG

Prescription Use : Yes

Device Count : 1

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