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510(k) Data Aggregation

    K Number
    K133299
    Device Name
    ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
    Manufacturer
    FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER
    Date Cleared
    2014-07-07

    (255 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.
    Device Description
    The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines. The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand). During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution. The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.
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