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    K Number
    K031502
    Device Name
    USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
    Manufacturer
    USFILTER
    Date Cleared
    2004-08-27

    (472 days)

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

    USFILTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
    Device Description
    The consistent mixing and delivery of bicarbonate solution for use in hemodialysis
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