BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    BAXTER S.A. DE C.V.

    Reg #: 8030639 · FEI: 6898 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    BAXTER S.A. DE C.V.
    Registration Number
    8030639
    FEI Number
    6898
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AV. DE LOS 50 METROS NO. 2
    City
    CIVAC, JIUTEPEC, MORELOS
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K072908

    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
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Hemodialyzer, Re-Use, High Flux MSF
    Dialyzer, Capillary, Hollow Fiber FJI
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ

    Proprietary Names

    PRISMASATE GAMBRO CARTRIDGE BLOOD SETS POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L MiniCap with Povidone-Iodine Solution Revaclear PrismaSATE dialysis solutions

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device