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    K Number
    K042426
    Device Name
    TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
    Manufacturer
    TAIJECT MEDICAL DEVICE CO., LTD.
    Date Cleared
    2004-09-22

    (14 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K031062,K022278
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    --- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.

    --- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.

    --- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.

    All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

    Device Description

    The TMD 1 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) is a single use, sterile, disposable syringes that is designed to reduce the risk of sharps injuries. The insulin syringe has scale lines in insulin units. The Tuberculin syringe has scale lines of Tuberculin.

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