BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gambro UF Solutions LLC

    Reg #: 3003504604 · FEI: 3003504604 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    Gambro UF Solutions LLC
    Registration Number
    3003504604
    FEI Number
    3003504604
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1405 Xenium Ln N, Suite 150
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152129

    Owner / Operator

    Firm Name
    Vantive US Healthcare LLC
    Operator Number
    9038727
    Address
    510 Lake Cook Road
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Jennifer Masek-Little

    Products

    Device Name Product Code
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    System, Peritoneal, Automatic Delivery FKX
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Clamp, Line FKK

    Proprietary Names

    MiniCap with Povidone-Iodine Solution Amia Automated PD System with Sharesource Cycler Set Homechoice Integrated APD Set with Cassette 3-prong Automated PD Set with Cassette 4-Prong Low Recirculation Volume APD Set with Cassette HomeChoice PRO Automated Personal Cycler PrisMax System Version 2 TherMax Cycler Sets for Peritoneal Dialysis MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short MiniCap Extended Life PD Transfer Set with Twist Clamp PrisMax System Version 3 15L Cycler Drainage Bag Effluent Sample Bag Automated Dialysis Cycler System Homechoice APD Set with Cassette 4 prong spike Short Nose Clamp for Outlet Port of Plastic Container UltraClamp Tubing Clamp PrisMax HomeChoice Personal Cycler Dialysis HomeChoice Low Recirculation Volume APD Set

    Establishment Types

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