QUEST MEDICAL INC

Address:1 Allentown Pkwy,ALLEN,TX,75002,US

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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

Heat-Exchanger, Cardiopulmonary Bypass (DTR) (10) Controller, Temperature, Cardiopulmonary Bypass (DWC) (4)

Premarket Exempt

No Yes

Clear

MPS Water Circuit Adapter, 16C - 20634624516117 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS2 Console - 20634624521265 Catalog Number :

Device Description : Myocardial Protection System (MPS) 2 console

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS2 console - 20634624522262 Catalog Number :

Device Description : MPS2 Console, 220 volt, 60 Hz

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS Power Cord, North America - 20634624524167 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : No

Device Count : 1

MPS Power Cord, North America, Refurbished - 20634624524174 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : No

Device Count : 1

MPS2 Console - 20634624524501 Catalog Number :

Device Description : MPS2 console, 240 volt, 50Hz

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Console - 20634624530106 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR, DWC

Prescription Use : Yes

Device Count : 1

MPS 3 Power cord - 20634624530168 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR, DWC

Prescription Use : Yes

Device Count : 1

MPS 3 Console Pole Mount - 20634624530236 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR, DWC

Prescription Use : Yes

Device Count : 1

MPS 3 Console Adapter - 20634624530250 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR, DWC

Prescription Use : Yes

Device Count : 1

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