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510(k) Data Aggregation

    K Number
    K221652
    Device Name
    NIKKICART
    Manufacturer
    Renal Care Dialysis Solutions, S.A. DE C.V.
    Date Cleared
    2023-03-03

    (269 days)

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

    Renal Care Dialysis Solutions, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NikkiCart cartridge is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure, chronic renal failure, or acute intoxication with dialyzable substances. The NikkiCart cartridge is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning machine on the Nikkiso DBB-06 dialysis system equipped with a compatible bicarbonate cartridge holder.
    Device Description
    The NikkiCart is a single use polypropylene (PP) cartridge containing dry sodium bicarbonate powder, which enables on-line preparation of saturated Sodium Bicarbonate solution that, in conjunction with appropriate acid concentrate solution and dialysis water, creates a bicarbonate -based dialysis fluid that meets the Association for the Advancement of Medical Instrumentation (AAMI) guidelines. When the NikkiCart is attached to the Nikkiso DBB-06 dialysis machine with a compatible bicarbonate cartridge holder, water is drawn by the dialysis machine through the cartridge, producing a saturated solution of sodium bicarbonate. The dialysis machine mixes the sodium bicarbonate solution with water and the acid concentrate to produce a bicarbonate-based dialysis fluid. The acid concentrate must have a dilution ratio of 1:44 also known as 45X to be used with the NikkiCart Sodium Bicarbonate cartridge.
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