BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiac Insulator

    Reg #: 1723241 · FEI: 1000517719 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GENESEE BIOMEDICAL, INC.
    Registration Number
    1723241
    FEI Number
    1000517719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 W Mississippi Ave Unit D5
    City
    DENVER
    State
    CO
    ZIP
    80223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K874927

    Owner / Operator

    Firm Name
    GENESEE BIOMEDICAL, INC.
    Operator Number
    9012312
    Address
    700 W Mississippi Ave, Unit D-5
    City
    Denver
    State
    CO
    Postal Code
    80223
    Country
    US
    Correspondent
    James Cross

    Products

    Device Name Product Code
    Controller, Temperature, Cardiopulmonary Bypass DWC

    Proprietary Names

    Cardiac Insulator

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility