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510(k) Data Aggregation

    K Number
    K023011
    Device Name
    OSMONICS SOLUTION DELIVERY SYSTEM
    Manufacturer
    OSMONICS MEDICAL SYSTEMS
    Date Cleared
    2003-06-26

    (290 days)

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

    OSMONICS MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.
    Device Description
    The Osmonics Solution Distribution System (SDS) provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.
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