BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Infusion Stand compact

    Reg #: 3002845651 · FEI: 3002845651 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XENIOS AG
    Registration Number
    3002845651
    FEI Number
    3002845651
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Obere Steinfurt 8-10
    City
    Stolberg North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191407

    Owner / Operator

    Firm Name
    Xenios AG
    Operator Number
    10045964
    Address
    Im Zukunftspark 1
    City
    Heilbronn
    State
    Baden-Wurttemberg
    Postal Code
    74076
    Country
    DE
    Correspondent
    Christiane Wagner

    US Agent

    Business Name
    Fresenius Medical Care North America
    Contact Name
    Denise M Oppermann
    Address
    920 Winter Street
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479

    Products

    Device Name Product Code
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ

    Proprietary Names

    Infusion Stand compact Support for backup pump drive Compact holder Novalung System XLung kit Novalung power supply Flow Sensor 3/8”x3/32” Trolley N Novalung battery pack IPS Pressure Sensor connecting cable Novalung control panel Novalung console Novalung pump drive DP3 Novalung sensor box

    Establishment Types

    Manufacture Medical Device