Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K133058
    Device Name
    INSULIN PEN NEEDLE
    Manufacturer
    WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
    Date Cleared
    2014-02-25

    (151 days)

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

    **WENZHOU WUZHOU IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
    Ask a Question
    K Number
    K110421
    Device Name
    DISPOSABLE INSULIN SYRINGE
    Manufacturer
    WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
    Date Cleared
    2011-04-26

    (71 days)

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

    **WENZHOU WUZHOU IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
    Device Description
    Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The proposed device of Disposable Insulin Syringe is a syringe with needle, consisting of a calibrated hollow barrel, a movable plunger, the needle cover and end cap. The needle is fixed on the syringe. The syringe is designed for manual use. The proposed device of Disposable Insulin Syringe is available in 0.3ml (U-100), 0.5ml (U-40, U-100), 1ml (U-40, U-100) volumes. The proposed device is provided sterilized.
    Ask a Question

    Page 1 of 1