B. BRAUN MEDICAL INC.

Address:1601 WALLACE DR., SUITE 150,CARROLLTON,TX,75006,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, i.V. Fluid transfer (LHI) (6) NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (2) Set, administration, intravascular (FPA) (2) Syringe, piston (FMF) (2)

Premarket Exempt

No Yes

Clear

Dispensing Pin - 04022495769688 Catalog Number : 412013

Device Description : Standard Spike Dispensing Pin

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 50

Mini-Spike® - 04022495769718 Catalog Number : 412020

Device Description : MINI-SPIKE® Dispensing Pin with One-Way Valve

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 50

Dispensing Pin - 04022495769725 Catalog Number : 412021

Device Description : Standard Spike Dispensing Pin with One-Way Valve

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 50

Dispensing Pin - 04022495769732 Catalog Number : 412022

Device Description : Non-Vented Dispensing Pin with One-Way Valve

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 50

Dispensing Pin - 04022495769749 Catalog Number : 413500

Device Description : Non-Vented Dispensing Pin with SAFSITE® Valve with Luer slip connector

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI, FPA

Prescription Use : Yes

Device Count : 50

Dispensing Pin - 04022495769756 Catalog Number : 413501

Device Description : Non-Vented Dispensing Pin with SAFSITE® Valve with Luer Lock Connector

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : LHI, FPA

Prescription Use : Yes

Device Count : 50

Disc Filter - 04022495769763 Catalog Number : 414995

Device Description : 1.2 Micron SUPOR® Aspiration / Injection Disc Filter

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 50

Disc Filter - 04022495769770 Catalog Number : 415002

Device Description : 0.2 Micron SUPOR® Aspiration / Injection Disc Filter

Device Class :

Duns Number: 002397347

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 50

MICRO-PIN® - 04022495769794 Catalog Number : 415019

Device Description : MICRO PIN® Non-Vented, Single-Use Dispensing Pin

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

Filter Straw - 04022495769800 Catalog Number : 415020

Device Description : FILTER STRAW® (FS5000)

Device Class :

Duns Number: 002397347

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 100

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