BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OptiVantage DH Injector System with Enhanced Communication

    Reg #: 1518293 · FEI: 1518293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Liebel-Flarsheim Company LLC
    Registration Number
    1518293
    FEI Number
    1518293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2111 EAST GALBRAITH RD.
    City
    Cincinnati
    State
    OH
    ZIP
    45237
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063503

    Owner / Operator

    Firm Name
    Guerbet LLC / Liebel-Flarsheim Company LLC
    Operator Number
    10050387
    Address
    214 Carnegie Center, Suite 300
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Injector, Contrast Medium, Automatic IZQ

    Proprietary Names

    OptiVantage DH Injector System with Enhanced Communication

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device