BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GAMBRO DASCO S.P.A., MONITORS DIVISION

    Reg #: 9616240 · FEI: 3002807196 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    GAMBRO DASCO S.P.A., MONITORS DIVISION
    Registration Number
    9616240
    FEI Number
    3002807196
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA MODENESE,66
    City
    MEDOLLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K083158

    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

    US Agent

    Business Name
    Baxter Healthcare Corporation
    Contact Name
    Jennifer Masek-Little
    Address
    510 Lake Cook Rd
    City
    Deerfield
    State
    IL
    ZIP
    60015
    Country
    US
    Email
    [email protected]
    Phone
    815 3548549

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    Exalis AK 98 Dialysis Machine CleanCart A, CleanCart C, AK 98 Dialysis Machine PrisMax System Version 2 TherMax Phoenix System PrisMax System Version 3

    Establishment Types

    Manufacture Medical Device