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510(k) Data Aggregation

    K Number
    K171805
    Device Name
    Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
    Manufacturer
    Date Cleared
    2017-09-08

    (81 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ConceptoMed AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer connectors.
    Device Description
    The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used.
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    K Number
    K162057
    Device Name
    ConceptoMed Luer-Jack Slip 10ml
    Manufacturer
    Date Cleared
    2017-01-11

    (169 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ConceptoMed AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors.
    Device Description
    The Luer-Jack Slip 10ml is a five-piece, single use syringe without needle, with a 6% (Luer) male slip connector. The device includes a three-piece syringe with a plastic barrel with graduated scale, a stopper and a plastic plunger rod. Upon the barrel is a single-handed needle hub release system in two pieces. The Luer-Jack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection the hub release system mounted upon the barrel is used. The Luer-Jack will be delivered sterilized by irradiation) in a hard blister pack (the Steri-Tilt™).
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