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510(k) Data Aggregation

    K Number
    K042426
    Device Name
    TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
    Date Cleared
    2004-09-22

    (14 days)

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

    TAIJECT MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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    K Number
    K031062
    Device Name
    TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
    Date Cleared
    2003-05-02

    (29 days)

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

    TAIJECT MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TMD™ 1ml Safety Syringe (FA11 Series 1ml) is designed as an anti-stick svringe to reduce the risk of sharps injuries and the potential for syringe reuse. It is a single use, disposable and manual retractable safety syringe that is intended for injection of fluids into the body after the aspiration of fluid. The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for use for subcutaneous injection of Insulin The TMD 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended to use for the three types of injection(subcutaneous, intra-dermal and intra-muscular) of Tuberculin.
    Device Description
    The TMD 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 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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    K Number
    K023458
    Device Name
    TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
    Date Cleared
    2002-11-07

    (23 days)

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

    TAIJECT MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of fluids into or withdraw from the body.
    Device Description
    The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is a sterile, single use and disposable, 10 ml & 20ml piston syringe, provided with or without needle in various product configurations. The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is similar in appearance, size, materials, operation, and purpose to other conventional single use, sterile, disposable syringes.
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    K Number
    K022278
    Device Name
    TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
    Date Cleared
    2002-09-12

    (59 days)

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

    TAIJECT MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    for the indications for use stated in the enclosure
    Device Description
    Not Found
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