BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HomeChoice Personal Cycler Dialysis

    Reg #: 2314912 · FEI: 2314912 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Vantive US Healthcare LLC
    Registration Number
    2314912
    FEI Number
    2314912
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1900 NORTH HIGHWAY 201
    City
    MOUNTAIN HOME
    State
    AR
    ZIP
    72653
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012988

    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

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    HomeChoice Personal Cycler Dialysis HomeChoice Low Recirculation Volume APD Set

    Establishment Types

    Manufacture Medical Device