BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Affinity NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber

    Reg #: 1928237 · FEI: 1928237 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIDWEST STERILIZATION CORP.
    Registration Number
    1928237
    FEI Number
    1928237
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1204 LENCO AVE.
    City
    JACKSON
    State
    MO
    ZIP
    63755
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183490

    Owner / Operator

    Firm Name
    MIDWEST STERILIZATION CORP.
    Operator Number
    1928237
    Address
    1204 LENCO AVE., --
    City
    Jackson
    State
    MO
    Postal Code
    63755
    Country
    US
    Correspondent
    KAREN E ELDRIDGE

    Products

    Device Name Product Code
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    Affinity NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber Affinity Fusion" Oxygenator with Integrated Arterial Filter with Balance" Biosurface Affinity NT" Integrated Uncoated CVR/Oxygenator with Cortiva" BioActive Surface Affinity Fusion" Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance" Biosurface Affinity NT" Oxygenator Affinity NT" Oxygenator with Cortiva" BioActive Surface Affinity Fusion" Oxygenator with Integrated Arterial Filter and Cortiva" BioActive Surface Affinity NT Integrated CVR/Membrane Oxygenator with Trillium Biosurface Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium" Biosurface Affinity Fusion" Oxygenator with Integrated Arterial Filter and Cortiva" BioActive Surface and Cardiotomy/Venous Reservo

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)