B. Braun Melsungen Aktiengesellschaft

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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

BOTTLE, COLLECTION, VACUUM (KDQ) (2) Parenteral Administration Kit (POR) (2) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

No Yes

Clear

Subcutaneous Injection Supply Kit - 04046955096756 Catalog Number :

Device Description : The parenteral administration kit is composed to support the home application of The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.

Device Class : 2

Duns Number: 315016972

Premarket Exempt : Yes

Product Code : POR

Prescription Use : Yes

Device Count : 1

Omnican® - 04046955143115 Catalog Number : 931A04US

Device Description : OMNICAN FINE 31G x 4MM GLUED W/O CAP US

Device Class : 2

Duns Number: 315016972

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Subcutaneous Injection Supply Kit 2 - 04046955251704 Catalog Number :

Device Class : 2

Duns Number: 315016972

Premarket Exempt : Yes

Product Code : POR

Prescription Use : Yes

Device Count : 1

ACCEL® - 04046964613371 Catalog Number : 622275

Device Description : 1000ML DRAINAGE BOTTLE, PVC-FREE

Device Class :

Duns Number: 315016972

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 10

ACCEL® - 04046964905063 Catalog Number : 622298

Device Description : 2000ML EVACUATED DRAINAGE BOTTLE

Device Class :

Duns Number: 315016972

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 6

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