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510(k) Data Aggregation

    K Number
    K222780
    Device Name
    LILY Extension Tube and Needleless Connector
    Date Cleared
    2023-11-09

    (421 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    LILY Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LILY Extension Tube and Needleless Connector is a sterile single patient use device for the administration of fluids from a container into the patient's vascular system through a vascular access device. It is for direct injection, continuous or intermittent infusion, aspiration and needle-free delivery of solutions during IV therapy.
    Device Description
    The LILY Extension Tube and Needleless is a closed luer activated device and passively aids in the reduction of needle stick injuries. Fluid flow through the device is activated by the ISO male luer from standard administration set, extension sets and syringes. The LILY Extension Tube and Needleless Connector provide a solid, sealed, surface for effective disinfection in 3 seconds. It is non-hemolytic. The clear housing and open, fluid filled design of the LILY Extension Tube and Needleless Connector enhance flushing particles. There is less volume of interstitial or dead space internal to the device. The LILY Extension Tube and Needleless Connector may be sued with power injection procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second.
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