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    K Number
    K050827
    Device Name
    NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
    Manufacturer
    DIALYSIS SOLUTIONS, INC.
    Date Cleared
    2005-08-22

    (143 days)

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

    DIALYSIS SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NORMOCARB 25 Sterile Bicarbonate Renal Dialysis Concentrate, after dilution, is indicated for use in Continuous Renal Replacement Therapy (CRRT).
    Device Description
    NORMOCARB™ 25 is a clear, sterile, apyrogenic, calcium-free bicarbonate renal dialysis concentrate provided in 240 ml unit-dose vials which, when diluted with water in the required proportions, creates a dialysis solution or dialysate for use in hemodialysis.
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