BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    B. BRAUN MELSUNGEN AG

    Reg #: 9610825 · FEI: 3002806469 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    95
    Establishment Types
    5
    Classifications
    26

    Registration Details

    Registration Name
    B. BRAUN MELSUNGEN AG
    Registration Number
    9610825
    FEI Number
    3002806469
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CARL-BRAUN-STR.1
    City
    MELSUNGEN Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K860126

    Owner / Operator

    Firm Name
    B. BRAUN MELSUNGEN AG
    Operator Number
    8010484
    Address
    CARL-BRAUN-STR.1, --
    City
    MELSUNGEN
    State
    DE-NOTA
    Postal Code
    34212
    Country
    DE
    Correspondent
    Kamaal Anas

    US Agent

    Business Name
    B. BRAUN MEDICAL, INC.
    Contact Name
    Kamaal Anas
    Address
    824 Twelfth Avenue
    City
    Bethlehem
    State
    PA
    ZIP
    18018
    Country
    US
    Email
    [email protected]
    Phone
    484 5231349

    Products

    Device Name Product Code
    Stimulator, Nerve, Battery-Powered BXN
    Syringe, Piston FMF
    Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact QEH
    Pump, Infusion FRN
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Anesthesia Conduction Kit CAZ
    Dispenser, Liquid Medication KYX
    Accessories, Pump, Infusion MRZ
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Pump, Infusion, Elastomeric MEB
    Catheter, Conduction, Anesthetic BSO
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Introducer, Catheter DYB
    Set, Administration, Intravascular FPA
    System, Dialysate Delivery, Central Multiple Patient FKQ
    Syringe, Irrigating (Non Dental) KYZ
    Needle, Hypodermic, Single Lumen FMI
    Dressing, Wound, Drug FRO
    Set, I.V. Fluid Transfer LHI
    Bottle, Collection, Vacuum KDQ
    Parenteral Administration Kit POR
    Device, Intravascular Catheter Securement KMK
    Accessories, Catheter KGZ
    Pump, Infusion, Pca MEA
    Pump, Infusion, Enteral LZH

    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 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 Omnican Pin Pad Perifix Pin Pad 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 IV stopcock Ganged Stopcock Perifix 0.2 Filter Sterifix Flat Epidural Filter Perfusor Space PCA Perican Hustead Perifix Epidural Needles Perican INT-Stopper Introcan Safety 3 Perfusor Brachial Plexus Anesthesia Kit Introcan Safety 2 Stimuplex HNS 12 Pencylcap

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device