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

Set, Administration, Intravascular (FPA) (6) Heat-Exchanger, Cardiopulmonary Bypass (DTR) (4) Controller, Temperature, Cardiopulmonary Bypass (DWC) (1)

Premarket Exempt

Yes No

Clear

Precision Delivery Trifurcated IV Extension Set - 00634624621114 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Precision Delivery Trifurcated IV Extension Set - 00634624621121 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Precision Delivery Trifurcated IV Extension Set - 00634624621138 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Precision Delivery Trifurcated IV Extension Set - 00634624621145 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Precision Delivery Trifurcated IV Extension Set - 00634624621152 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Precision Delivery Trifurcated IV Extension Set - 00634624621169 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

MPS 3 Mini Prime Delivery Set w/AA - 00634624700314 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

MPS® Mini-Prime Delivery Set - 00634624701113 Catalog Number :

Device Description : MPS® Mini-Prime Delivery Set with Arrest and Additive Cassettes

Device Class :

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS® Low Volume Delivery Set - 00634624701120 Catalog Number :

Device Description : MPS® Low Volume Delivery Set

Device Class :

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS® Extension Tubing, 6 ft. x 3/16 in. - 00634624701137 Catalog Number : 7001103

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

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