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) (4) Heat-Exchanger, Cardiopulmonary Bypass (DTR) (2) Suction Control, Intracardiac, Cardiopulmonary Bypass (DWD) (2) Controller, Temperature, Cardiopulmonary Bypass (DWC) (1) Cpb Check Valve, Retrograde Flow, In-Line (MJJ) (1) Instruments, Surgical, Cardiovascular (DWS) (1)

Premarket Exempt

No Yes

Clear

48 in (122 cm) CheckMate Extension Set - 00634624096219 Catalog Number : 9621

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Checkmate IV Administration Set 123in (312 cm) - 00634624096523 Catalog Number : 9652

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Checkmate Extension Set 36 inch (91cm) - 00634624096578 Catalog Number : 9657

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Aortotomy System Lancet 3.3mm - 00634624175334 Catalog Number :

Device Class : 1

Duns Number: 041810693

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

75inch Vented IV administration Set - 00634624222014 Catalog Number : 22-201V

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

RLV-2100 "B" Vacuum Relief Valve - 00634624413122 Catalog Number : 4103102

Device Class : 2

Duns Number: 041810693

Premarket Exempt : Yes

Product Code : DWD

Prescription Use : Yes

Device Count : 1

RLV-T Suction Control Device - 00634624431058 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : Yes

Product Code : DWD

Prescription Use : Yes

Device Count : 1

RetroGuard Arterial Safety Valve - 00634624471009 Catalog Number : 4007100

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : MJJ

Prescription Use : Yes

Device Count : 1

MPS - 00634624500112 Catalog Number :

Device Description : Dual Spike Crystalloid Y Adapter

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

MPS 3 Delivery Set w/183cm (10C) - 00634624500310 Catalog Number :

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : DWC, DTR

Prescription Use : Yes

Device Count : 1

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