BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    B. Braun Avitum Italy S.p.A.

    Reg #: 9681240 · FEI: 3007033498 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    B. Braun Avitum Italy S.p.A.
    Registration Number
    9681240
    FEI Number
    3007033498
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA XXV LUGLIO 11
    City
    MIRANDOLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K073538

    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
    Container, I.V. KPE
    Set, I.V. Fluid Transfer LHI
    System/Device, Pharmacy Compounding NEP

    Proprietary Names

    EVA Dual Chamber Mixing Container for use w/ Apex Compounding System EVA Dual Chamber Mixing Container for use w/ Pinnacle TPN Management Systems High Flow Y-Adapter Transfer set w/ Pinnacle TPN Management System Tamper Resistant Clamp EVA Mixing Container for use with Gravity Transfer EVA Mixing Container for use with Apex Compounding System EVA mixing Container for use w/ Pinnacle TPN Management System Universal Spike APEX Compounding System Calibration Container XVIVO Click Adapter

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)