Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610825

FEI Number

3002806469

Entity Name

B. BRAUN MELSUNGEN AG

City/State/Country

MELSUNGEN Hesse, DE

Establishment Address

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

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

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

K072876

PMA Number

N/A

All Registered Proprietary Names

Stimuplex Omnifix Syringe NRFit Infusomat Infusion P Vista Basic Vista Basic Spinal tray Spinal needle Spinocan Continuous Nerve Block Needles Contiplex Tuohy / Straight Nerve Block Support Trays Continuous Nerve Block Sets/Tray Periphal Nerve Blocks Exadoral Pencan SpaceStation MRI Xevonta Ultraplex Stimuplex Ultra Stimuplex D Contiplex D Stimuplex Ultra 360 Ultraplex 360 Nerve Block Support Trays ( kits) Continuous Nerve Block Sets and Trays (kits) EasyPump Perfusor Space Perfusor Space ACM PERIFIX EPIDURAL ANESTHESIA SETS PERIFIX CATHETER CONNECTOR Stopcock Manifold Discofix Contiplex C Infusomat Space Pump Diacap Ultra Perifix Perifix Pediatric Continuous Epidural Sets/ Trays Omnifix Omnican fine Perifix Catheter Connector NORM-JECT Injekt Introcan Safety 2 (multi) Deep Access Prontosan Espocan Espocan Combined Spinal/Epidural Needle sets trays Prontosan Mini-Spike Chemo Dispensing Pin Pencan and Spinocan Spinal Needles with/without Introducer Spinal Needle/ Spinal Tray Drainage Bottle ACCEL Evacuated Drainage Bottle Red Cap Combi Stopper Red Cap Blue Cap Introcan Safety 2 (multi) Infusomat Space Modified Stimuplex HNS 12 Stimuplex Switch Perifix ONE Pediatric Catheter Perifix LOR Perifix Plastic Loss of Resistance Syringe Epican Epican Epidural Cannula Sterican Soft Tip Catheter Perifix Soft Tip Catheter Diacap Pro Subcutaneous Injection Supply Kit Omnifix Omnican Perifix Pin Pad Perifix Pin Pad Infusomat Space Infusomat Space ACM Mini Spike Plus 6/8R Perican Tuohy Needle Perifix Catheter Perifix Basic Intermediate dose and continuous epidural tray Perifix Filter Sets Perifix continuous epidural tray Perifix mini sets Perifix Basic Single dose and continuous epidural tray Perifix Prontosan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2007-11-20
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
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-11-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2009-11-30
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2017-12-05
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-15
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-08-03
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2020-08-03
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-04-02
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2010-05-21
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2013-11-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-11-20
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2006-11-29
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2006-11-29
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2009-12-03
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-11-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-11-20
FKQ	System, Dialysate Delivery, Central Multiple Patient	Gastroenterology, Urology	Class 2	876.5820	2025-04-02
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2007-11-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-10-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-09-07
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2007-11-20
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-05-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-08-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-05-31
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-12-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-11-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-01-30
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-05-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-10-14
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2011-05-02
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2009-09-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-05-11
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2011-05-11
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-08-16
POR	Parenteral Administration Kit	General Hospital	Class 2	880.5440	2017-05-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-07
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-06
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2011-05-24
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2009-12-07
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-06-01
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2006-11-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-06-24

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
8031007	B. BRAUN MEDICAL AG	ESCHOLZMATT Luzern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K860126	Burron Medical Products, Inc.	STIMUPLEX, NERVE STIMULATOR	1986-02-28
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
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30

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
3004748541	Salter Labs	El Paso, TX, US
2022648	Anesthesia Associates, Inc.	SAN MARCOS, CA, US
3001650535	Suzhou Meccan Import and Export Corp.	Suzhou Jiangsu, CN
2183613	NORTECH SYSTEMS, INC.	Milaca, MN, US
9611481	HAKKO CO., LTD.	CHIKUMA-SHI Nagano, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610825. Last updated year: 2026. Please use registration number 9610825 when referencing this establishment in official correspondence.