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    FDA Registration Active 🇮🇹 Italy

    GAMBRO DASCO S.P.A., BLOOD LINE DIVISION

    Reg #: 9610270 · FEI: 3012394756 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    6

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    Registration Details

    Registration Name
    GAMBRO DASCO S.P.A., BLOOD LINE DIVISION
    Registration Number
    9610270
    FEI Number
    3012394756
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA MODENESE, 66
    City
    MEDOLLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K232467

    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
    Vantive US Healthcare LLC
    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
    Subsystem, Water Purification FIP
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    System, Hemodialysis, Remote Accessories MON
    System, Peritoneal, Automatic Delivery FKX
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    CleanCart A, CleanCart C, AK 98 Dialysis Machine U9000 Ultrafilter AK 98 Dialysis Machine C-705 Accessory Expansion Chamber Sterile Bag 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 PRISMASATE BICART

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device