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510(k) Data Aggregation

    K Number
    K991003
    Device Name
    PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
    Manufacturer
    DAYSPRING MEDICAL, INC.
    Date Cleared
    1999-06-09

    (76 days)

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

    FKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a sample of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile. The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.
    Device Description
    Pump Segment Rinse Lines & T-Connectors Pump segment rinse line w/ slip-on connector (Our Catalog No. PS100R) Pump segment rinse line w/ luer-lock connector (Our Catalog No. PS100B) T-connector, short, w/ slip-on connector (Our Catalog No. ST100R) T-connector, short, w/ luer-lock connector (Our Catalog No. ST100B) T-connector, long, w/ slip-on connector (Our Catalog No. LT100R) T-connector, long, w/ luer-lock connector (Our Catalog No. LT100B) The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector. The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer. The luer-lock, screw-on connector securely screws on to the "male" end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frotion seal that prevents any fluids from leaking out of the dia
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