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) (5)

Premarket Exempt

No Yes

Clear

MPS 3 Delivery Set w/AA w/183 Line (10C) - 00634624500327 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Delivery Set w/AA w/106cm (10C) - 00634624500334 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Delivery Set w/AA w/106cm (16C) - 00634624500341 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Delivery Set w/183cm (16C) - 00634624500358 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Delivery Set w/AA w/183 Line (16C) - 00634624500365 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS Delivery Set - 00634624501102 Catalog Number : 5001100

Device Description : No Arrest/Additive Cassettes, has 106cm line.

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624501126 Catalog Number :

Device Description : MPS® Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. MPS® Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624501133 Catalog Number :

Device Description : MPS Delivery Set with arrest agent or additive cassettes, 183 cm extension line

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624501140 Catalog Number :

Device Description : MPS® Arrest Agent Cassette

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS - 00634624501157 Catalog Number :

Device Description : MPS® Additive Agent Cassette

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

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