BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PrismaSATE dialysis solutions

    Reg #: 8030639 · FEI: 6898 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BAXTER S.A. DE C.V.
    Registration Number
    8030639
    FEI Number
    6898
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AV. DE LOS 50 METROS NO. 2
    City
    CIVAC, JIUTEPEC, MORELOS
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K162887

    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
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    PrismaSATE dialysis solutions

    Establishment Types

    Manufacture Medical Device