BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    B. Braun Avitum AG

    Reg #: 3002879653 · FEI: 3002879653 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    47
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    B. Braun Avitum AG
    Registration Number
    3002879653
    FEI Number
    3002879653
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Buschberg 1
    City
    MELSUNGEN Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K083460

    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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Pump, Infusion FRN
    Subsystem, Water Purification FIP
    Pump, Infusion, Pca MEA
    Pump, Infusion, Enteral LZH
    Medical Device Data System OUG

    Proprietary Names

    Dialog+ Adimea Dialog+ ABPM Cuff Infusomat Space Aquaboss® EcoRO Dia I 700 HT Aquaboss® EcoRO Dia I 2800 Aquaboss® EcoRO Dia II 1400 HT Aquaboss® EcoRO Dia II 900 Aquaboss® EcoRO Dia II 2800 HT Aquaboss® EcoRO Dia II 1800 Aquaboss® EcoRO Dia I 2450 HT Aquaboss® EcoRO Dia II 1050 Aquaboss® EcoRO Dia II 900 HT Aquaboss® EcoRO Dia II 2100 Aquaboss® EcoRO Dia I 1400 Aquaboss® EcoRO Dia I 700 Aquaboss® EcoRO Dia I 2100 Aquaboss® EcoRO Dia I 3600 Aquaboss® EcoRO Dia II 1400 Aquaboss® EcoRO Dia II 1050 HT Aquaboss® EcoRO Dia I 1250 Aquaboss® EcoRO Dia I 3600 HT Aquaboss® EcoRO Dia II 700 HT Aquaboss® EcoRO Dia II 2100 HT Aquaboss® EcoRO Dia II 2800 Aquaboss® EcoRO Dia I 2450 Aquaboss® EcoRO Dia II 2450 Aquaboss® EcoRO Dia I 1050 Aquaboss® EcoRO Dia I 2100 HT Aquaboss® EcoRO Dia II 2450 HT Aquaboss® EcoRO Dia I 1800 HT Aquaboss® EcoRO Dia II 3600 Aquaboss® EcoRO Dia I 1400 HT Aquaboss® EcoRO Dia II 1800 HT Aquaboss® EcoRO Dia I 2800 HT Aquaboss® EcoRO Dia I 900 HT Aquaboss® EcoRO Dia I 1800 Aquaboss® EcoRO Dia I 1250 HT Aquaboss® EcoRO Dia II 700 Aquaboss® EcoRO Dia I 1050 HT Aquaboss® EcoRO Dia II 3600 HT Aquaboss® EcoRO Dia II 1250 AQUAbase nX HT AQUAbase nX Perfusor Space Perfusor Option WAN-BSL

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198