BEUDAMED
    FDA Registration Active 🇺🇸 United States

    400CE

    Reg #: 1516825 · FEI: 1516825 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gentherm Medical, LLC
    Registration Number
    1516825
    FEI Number
    1516825
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12011 MOSTELLER RD
    City
    Cincinnati
    State
    OH
    ZIP
    45241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122813

    Owner / Operator

    Firm Name
    Gentherm Medical LLC
    Operator Number
    1516825
    Address
    12011 MOSTELLER RD.
    City
    Cincinnati
    State
    OH
    Postal Code
    45241
    Country
    US
    Correspondent
    JONATHAN KOVACH

    Products

    Device Name Product Code
    Controller, Temperature, Cardiopulmonary Bypass DWC

    Proprietary Names

    400CE 414CE

    Establishment Types

    Manufacture Medical Device