BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Integrated APD Set with Cassette 3-prong

    Reg #: 9610270 · FEI: 3012394756 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GAMBRO DASCO S.P.A., BLOOD LINE DIVISION
    Registration Number
    9610270
    FEI Number
    3012394756
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA MODENESE, 66
    City
    MEDOLLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K102936

    Owner / Operator

    Firm Name
    Vantive US Healthcare LLC
    Operator Number
    9038727
    Address
    One Baxter Parkway, Building 6
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Jennifer Masek-Little

    US Agent

    Business Name
    Vantive US Healthcare LLC
    Contact Name
    Jennifer Masek-Little
    Address
    25212 W Il Route 120
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2707027

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    Integrated APD Set with Cassette 3-prong Homechoice Automated PD Set with Cassette 4-Prong HomeChoice PRO Automated Personal Cycler Low Recirculation Volume APD Set with Cassette

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device