BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    POLYFLUX 14L, 17L, 21L

    Reg #: 9611369 · FEI: 3002807035 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GAMBRO DIALYSATOREN GMBH
    Registration Number
    9611369
    FEI Number
    3002807035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HOLGER - CRAFOORD - STRASSE 26
    City
    HECHINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K043342

    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
    Hemodialyzer, Re-Use, High Flux MSF
    Dialyzer, Capillary, Hollow Fiber FJI
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    POLYFLUX 14L, 17L, 21L POLYFLUX 140H, 170H, 210H

    Establishment Types

    Manufacture Medical Device