BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRIFURCATED EXTENSION, NEEDLEFREE VALVES

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FENWAL, INC.
    Registration Number
    3004548776
    FEI Number
    3004548776
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 CORPORATE DR STE 300
    City
    LAKE ZURICH
    State
    IL
    ZIP
    60047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001872

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    TRIFURCATED EXTENSION, NEEDLEFREE VALVES EXTENSION SET, 2 -NEEDLEFREE VALVES 60D VENTED, Y-NEEDLEFREE VALVE 20D NON-VENTED, INLINE BCV, NEEDLEFREE EXTENSION SET, NEEDLEFREE VALVE 60D VENTED, 2 NEEDLEFREE VALVES 60 IN. EXTENSION SET W/ NEEDLEFREE VALVE EXTENSION T-CONNECTOR, NEEDLEFREE VALVE 20D NON-VENTED, 2 NEEDLEFREE VALVES 60D VENTED, BCV, 3 NEEDLEFREE VALVES 60D VENTED, 3 NEEDLEFREE VALVES BIFURCATED EXTENSION, NEEDLEFREE VALVE 60D VENTED, BCV,Y-NEEDLEFREE VALVE 20D NON-VENTED, BCV, 3 NEEDLEFREE VALVES 20D NON-VENTED, BCV, 2 NEEDLEFREE 4 IN. EXTENSION SET, NEEDLEFREE VALVE 20D NON-VENTED, NEEDLEFREE VALVE 20D NON-VENTED, 3 NEEDLEFREE VALVES 6 IN. EXTENSION SET, NEEDLEFREE VALVE 60D VENTED, BCV, 2 NEEDLEFREE VALVES

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198