Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031007

FEI Number

5637

Entity Name

B. BRAUN MEDICAL AG

City/State/Country

ESCHOLZMATT Luzern, CH

Establishment Address

HAUPTSTRASSE 39, ESCHOLZMATT Luzern CH-6182, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

B. BRAUN MELSUNGEN AG (Owner Number: 8010484)

Owner / Operator Contact Address

CARL-BRAUN-STR.1, --, MELSUNGEN, DE-NOTA 34212, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV stopcock Ganged Stopcock Discofix Omnifix Omnican Omnifix Syringe NRFit Mini Spike Plus 6/8R

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-12-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-23
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	General Hospital	Class 2	880.5860	2024-07-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-06-01

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN MELSUNGEN AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005694677	B. Braun Medical S.A.	Crissier Vaud, CH
9680474	B. BRAUN MEDICAL, LTD.	GYONGYOS Heves, HU
3007120504	B. Braun Medical AG	Sempach Luzern, CH
9680591	B. BRAUN AESCULAP JAPAN CO., LTD.	TOCHIGI, JP
9610825	B. BRAUN MELSUNGEN AG	MELSUNGEN Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
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3005334138	St. Jude Medical, Cardiology Division, Inc.	Plymouth, MN, US
3020460367	BOUND TREE MEDICAL, LLC	Grand Prairie, TX, US
3003528228	HOSPITECH MANUFACTURING SERVICES SDN BHD	Shah Alam Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031007. Last updated year: 2026. Please use registration number 8031007 when referencing this establishment in official correspondence.