B. BRAUN MEDICAL INC.

Address:824 12th Ave,BETHLEHEM,PA,18018,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

Anesthesia conduction kit (CAZ) (4) NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (4) Set, administration, intravascular (FPA) (1) Syringe, piston (FMF) (1)

Premarket Exempt

No Yes

Clear

Injekt® - 04022495252074 Catalog Number : 9166017V

Device Description : Injekt®-F (1 ml) (9166017V)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 100

Filter Straw - 04022495284129 Catalog Number : 415021

Device Description : FILTER STRAW® (FS5005)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

Filter Needle - 04022495284860 Catalog Number : 415041

Device Description : High Flow Filter Needle

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

Filter Needle - 04022495285782 Catalog Number : 415025

Device Description : Filter Needle (FN5120)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

Filter Needle - 04022495285799 Catalog Number : 415030

Device Description : Filter Needle (FN5119)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

CONTIPLEX® - 04022495769480 Catalog Number : 331691

Device Description : Contiplex® Tuohy Set, 18 Ga. X 2 in. Insulated Needle (CNB200T)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 12

CONTIPLEX® - 04022495769497 Catalog Number : 331693

Device Description : Contiplex® Tuohy Set, 18 Ga. X 4 in. Insulated Needle (CNB400)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 12

CONTIPLEX® - 04022495769503 Catalog Number : 331694

Device Description : Contiplex® Tuohy Set, 18 Ga. X 6 in. Insulated Needle (CNB600)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 12

CONTIPLEX® - 04022495769510 Catalog Number : 331695

Device Description : Contiplex® Tuohy Set, 18 Ga. X 1-1/2 in. Insulated Needle (CNB150)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 12

Fluid Transfer Set - 04022495769558 Catalog Number : 356048

Device Description : Fluid Transfer Set (FT1005S)

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

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