BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Revaclear

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

    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
    K130039

    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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    Revaclear

    Establishment Types

    Manufacture Medical Device