B. BRAUN MEDICAL INC.

Address:2525 MCGAW AVE.,IRVINE,CA,92614,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

Nerve block tray (OGJ) (5) Anesthesia conduction kit (CAZ) (3) PUMP, INFUSION, ENTERAL (LZH) (1) Pump, infusion (FRN) (1) Set, administration, intravascular (FPA) (1)

Premarket Exempt

No Yes

Clear

Extension Set - 04046964991295 Catalog Number : 490478

Device Description : EXTENSION SET, 16 IN

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 24

Contiplex® - 04046964991394 Catalog Number : 331766

Device Description : Contiplex® Echo Set, Open-tip Echogenic Catheter with 18 Ga. x 4 in. Insulated E Contiplex® Echo Set, Open-tip Echogenic Catheter with 18 Ga. x 4 in. Insulated Echogenic Tuohy (CNB400TU3EO)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : CAZ

Prescription Use : Yes

Device Count : 10

Contiplex® - 04046964991417 Catalog Number : 331767

Device Description : Contiplex® Echo Set, Closed-tip Echogenic Catheter with 18 Ga. x 2 in. Insulated Contiplex® Echo Set, Closed-tip Echogenic Catheter with 18 Ga. x 2 in. Insulated Echogenic Tuohy (CNB200TU3EC)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : CAZ

Prescription Use : Yes

Device Count : 10

Contiplex® - 04046964991431 Catalog Number : 331768

Device Description : Contiplex® Echo Set, Closed-tip Echogenic Catheter with 18 Ga. x 4 in. Insulated Contiplex® Echo Set, Closed-tip Echogenic Catheter with 18 Ga. x 4 in. Insulated Echogenic Tuohy (CNB400TU3EC)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : CAZ

Prescription Use : Yes

Device Count : 10

Contiplex® - 04046964991486 Catalog Number : 332142

Device Description : Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 2 in. Insulated Echogenic Needle Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 2 in. Insulated Echogenic Needle and Non-Stimulating Catheter - Includes UltrasoundTransducer Cover and Gel (CNB200TU3KU)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 10

CONTIPLEX® - 04046964991509 Catalog Number : 332143

Device Description : Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 4 in. Insulated Echogenic Needle Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 4 in. Insulated Echogenic Needle and Non-Stimulating Catheter - Includes UltrasoundTransducer Cover and Gel (CNB400TU3KU)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 10

CONTIPLEX® - 04046964991523 Catalog Number : 331640

Device Description : Contiplex® Tuohy Ultra 360 Set, 18 Ga. X 2 in. Insulated Echogenic Needle (CNB200TU3)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 12

CONTIPLEX® - 04046964991547 Catalog Number : 331641

Device Description : Contiplex® Tuohy Ultra 360 Set, 18 Ga. X 4 in. Insulated Echogenic Needle (CNB400TU3)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 12

CONTIPLEX® - 04046964991561 Catalog Number : 331642

Device Description : Contiplex® Tuohy Ultra 360 Set, 18 Ga. X 6 in. Insulated Echogenic Needle (CNB600TU3)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 12

NA - 04046964993459 Catalog Number : 8713140U-99

Device Description : SPACE STATION ASSET

Device Class : 2

Duns Number: 002397347

Premarket Exempt : No

Product Code : FRN, LZH

Prescription Use : Yes

Device Count : 1

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