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510(k) Data Aggregation

    K Number
    K120375
    Device Name
    MED-RX PATIENT DELIVERY SET
    Manufacturer
    Date Cleared
    2012-06-28

    (143 days)

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

    BENLAN INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images.
    Device Description
    The MED-RX® Patient Delivery Sets each consist of a male luer lock, two female luer locks, 3 tubing pieces, and either a dual check valve, a single check valve, or a Y-connector. The tube is made of polyvinyl chloride (PVC). The total length of the sets varies from 18″ to 86″ and is also available in a coiled configuration. The MED-RX® Patient Delivery Sets are provided sterile and are not to be resterilized.
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    K Number
    K112799
    Device Name
    MED-RX EXTENSION SET WITH T-CONNECTOR
    Manufacturer
    Date Cleared
    2011-12-23

    (87 days)

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

    BENLAN INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.
    Device Description
    The MED-RX Extension Set with T-Connector is offered in two configurations, identical except for the tubing length. The proximal end of the MED-RX Extension Set with T-Connector features a T-Connector with an injection port and an integral rotating male luer lock. The distal end has a female luer lock fitting. The inner and outer diameter of both devices is consistent at 0.040" and 0.095" respectively, while the lengths available are either 4" or 38". Each of the luer fittings (distal female luer lock and proximal rotating male luer lock) are provided with protective caps. The MED-RX Extension Set with T-Connector is provided sterile and is single use.
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