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510(k) Data Aggregation

    K Number
    K982813
    Device Name
    NATURALYTE, MODEL # 08-4004-1
    Manufacturer
    Date Cleared
    1998-11-06

    (87 days)

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

    KAYBATH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population
    Device Description
    KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.
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