BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    B. Braun Avitum AG

    Reg #: 3004176176 · FEI: 3004176176 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    B. Braun Avitum AG
    Registration Number
    3004176176
    FEI Number
    3004176176
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KATTENVENNER STR. 32
    City
    GLANDORF Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K052393

    Owner / Operator

    Firm Name
    B. BRAUN Avitum AG
    Operator Number
    9057188
    Address
    Schwarzenberger Weg 73-79, --
    City
    MELSUNGEN
    State
    DE-NOTA
    Postal Code
    D-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
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Disinfectant, Medical Devices LRJ
    System, Dialysate Delivery, Central Multiple Patient FKQ
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    B Braun Modified Bicarbonate Dialysate Solcart B Solcart B 760g Solcart B 650g Citric Acid 50% Citric Acid B. Braun Bicarbonate Dialysate Solcart B 1100g DIACAP ULTRA PureFlow B Solution NxtStage Pureflow Solution xevonta Diacap Pro

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device