BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    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

    PMA Number
    BP850001

    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
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT Plasmacell-C Disposable Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198