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510(k) Data Aggregation

    K Number
    K121554
    Device Name
    Q-FLO CLOSED MALE LUER CONNECTOR
    Date Cleared
    2012-06-08

    (14 days)

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

    INFUSION INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Q-Flo™ Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.
    Device Description
    The Q-Flo™ Closed Male Luer Connector is a sterile, non-pyrogenic, and single-use luer device. It enables clinical personnel to handle fluids, including hazardous materials such as chemotherapy, radioactive isotopes, and blood products when used in conjunction with a compatible female luer connector. This includes the preparation and administration of fluids to the patient and waste handling. This provides access for the administration of fluids from a container to a patient's vascular system through an administration needle or catheter which is inserted into an artery or vein. The Q-Flo™ CML connector uses a sequential locking mechanism with a colored visual indicator to provide the user with confirmation of the status of the connection. There are three (3) connection states possible. When the device is not connected to a female luer it is closed and drip-less. When the device is connected to a female luer but the connection is deactivated, the visual indicator is not present and no flow is permitted. Continuing to turn the device and female luer connection together actuates the connection and opens the system to permit flow. The Q-Flo™ CML connector utilizes the engagement of the luer threads to open the fluid path and, with the silicone sealing member, to provide a leak free state. The action of the thread engagement moves the male luer connector forward and visible to the used thus giving visual confirmation of full connection. The Q-Flo™ CML connector has been designed with a weight and size to be consistent with IV administration set connections. It weighs less than 2.5 grams and is 12.8 mm in diameter.
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