BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Affinity Fusion™ Oxygenator with Integrated Arterial Filter Biosurface Reservoir, Blood, Cardiopulmonary Bypass

    Reg #: 1928237 · FEI: 1928237 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    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
    K240666

    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
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Oxygenator, Cardiopulmonary Bypass DTZ
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM

    Proprietary Names

    Affinity Fusion™ Oxygenator with Integrated Arterial Filter Biosurface Reservoir, Blood, Cardiopulmonary Bypass Affinity Fusion™ Oxygenator with Integrated Arterial Filter Biosurface Oxygenator, Cardiopulmonary Bypass Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface; Affinity Fusion™ Oxygenator with In

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)