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510(k) Data Aggregation

    K Number
    K991005
    Device Name
    VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
    Manufacturer
    DAYSPRING MEDICAL, INC.
    Date Cleared
    1999-06-22

    (89 days)

    Product Code
    LLB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    LLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are used for capping off the two dialysate port access ends of a hollow fiber dialyzer. The devices are used by technicians in a dialysis unit during the cleaning, reprocessing, and disinfecting of the dialyzer. During the disinfecting procedure, the technician fills the dialyzer with a sterilant solution that sterilizes the inner filter membrane of the dialyzer. The dialysate port caps prevent the large-scale leakage of the fluid stored inside the dialyzer. The vented dialysate port caps, in the process of venting pressure, may leak a very small amount of fluid. The device replaces the original equipment manufacturer's closure ports after the initial use of the dialyzer.
    Device Description
    The devices are clean, but not sterile. The inside opening of the caps are tapered to match the standard dialysate ports found on hollow fiber dialyzers. The devices mate directly to the dialysate port. The caps are affixed by placing the open end of the cap over the "male" end of the dialysate ports. They are released by pulling them straight off. The surface of the dialysate port and the surface of the dialysate port cap device meet, and create a friction seal that prevents stored fluids from leaking out of the dialyzer. The vented dialysate port cap has a po-up piece at the top of the device. These vented caps are specifically for use with a sterilant solution known as Renalin, and manufactured by Minntech Corp. This sterilant is known to create pressure inside the dialyzer. The vented cap is a device to relieve this pressure buildup.
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