BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ivenix Infusion System (IIS)

    Reg #: 3014732157 · FEI: 3014732157 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Fresenius Kabi USA, LLC
    Registration Number
    3014732157
    FEI Number
    3014732157
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 High Street, Suite 50
    City
    North Andover
    State
    MA
    ZIP
    01845
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183311

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Infusion Safety Management Software PHC
    Pump, Infusion FRN
    Set, Administration, Intravascular FPA

    Proprietary Names

    Ivenix Infusion System (IIS)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device