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510(k) Data Aggregation

    K Number
    K033118
    Device Name
    BIPRO MODEL SDS-CB200
    Manufacturer
    MEDICAL SOLUTIONS INTERNATIONAL
    Date Cleared
    2004-06-28

    (272 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SOLUTIONS INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.
    Device Description
    The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb concentrates and RO water for distribution as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine.
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