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510(k) Data Aggregation

    K Number
    K132557
    Device Name
    EWNL SAFETY SYRINGE WITH NEEDLE
    Date Cleared
    2014-06-03

    (293 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    JIAMEI-UN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EWNLTM Safety Syringe with Needle (1mL, 2 mL, 3 mL, and 10 mL) is a sterile, single-use, disposable and non-reusable manual retractable safety svringe, intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse. This syringe is intended to be used by nurse, clinicians, or professional healthcare providers only.
    Device Description
    EWNL " Safety Syringe with Needle is a sterile, single-use, disposable, non-reusable, manual retractable safety syringe provided with needle. EWNL™ Safety Syringe is intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. The device is intended for injection of fluids into, or withdrawal from, the body. The function of EWNL " Safety Syringe works the same as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe barrel after the injection. Needle retraction is activated manually by the syringe user. The device also features a destructible plunger, which can be pulled back, snapped off, and the entire unit disposed of after the needle is locked inside the syringe barrel. With this sharps injury prevention design, the svringe user is protected from accidental needle sticks.
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