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

Tubing, Fluid Delivery (FPK) (6) Set, Administration, Intravascular (FPA) (4)

Premarket Exempt

No Yes

Clear

Q2® Needleless injection site - 00634624031500 Catalog Number : 3150

Device Class :

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

6" (15 cm) Microbore Extension Set with Clamp - 00634624090651 Catalog Number :

Device Description : 6" (15 cm) Microbore Intravascular Extension Set with Clamp

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

42 in(107cm) Extension Set w/ 2 check valves - 00634624092198 Catalog Number : 9219

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 1

7 in (18cm) Y-Extension Set w/ 2 check valves - 00634624092501 Catalog Number : 9250

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 1

44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site - 00634624095410 Catalog Number : 9541

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 1

Q2 Checkmate Extension Set - 00634624095434 Catalog Number :

Device Description : 44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detac 44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detachable. Approximate priming volume 6.4mL.

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

10 in. (25 cm) Q2 Checkmate extension set - 00634624095458 Catalog Number : 9545

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 1

18 in (46 cm) Q2 Extension set w/ standard bore tubing - 00634624095465 Catalog Number : 9546

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 1

6 in. (15 cm) CheckMate Extension set - 00634624096004 Catalog Number : 9600

Device Class :

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

44 in (112 cm) CheckMate Extension set - 00634624096202 Catalog Number : 9620

Device Class : 2

Duns Number: 041810693

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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