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 3 Additive Cartridge - 00634624531055 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Arrest Agent Delivery Line - 00634624531062 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Additive Delivery Line - 00634624531079 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Blood Bypass Tubing - 00634624531161 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624551114 Catalog Number :

Device Description : MPS® Retrograde external pressure line w/pressure transducer

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624551121 Catalog Number :

Device Description : MPS® Retrograde extension pressure line w/Y-set

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624551138 Catalog Number :

Device Description : MPS® Pressure Line w/transducer

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624551176 Catalog Number :

Device Description : MPS® Retrograde extension line without transducer

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Delivery Set 16C w/ AA 35cm Line - 00634624561120 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : No

Device Count : 1

Delivery Set 16C w/ AA 183cm Line - 00634624561144 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

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