BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Automated Dialysis Cycler System

    Reg #: 3003504604 · FEI: 3003504604 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gambro UF Solutions LLC
    Registration Number
    3003504604
    FEI Number
    3003504604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1405 Xenium Ln N, Suite 150
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K923065

    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

    Automated Dialysis Cycler System Homechoice APD Set with Cassette 4 prong spike Effluent Sample Bag

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility