Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K120420
    Device Name
    STERILE BLUNT FOR SINGLE USE
    Manufacturer
    SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
    Date Cleared
    2012-10-18

    (251 days)

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

    SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Blunt for Single Use includes two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid. The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
    Device Description
    The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System. The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle. Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.
    Ask a Question
    K Number
    K090929
    Device Name
    STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
    Manufacturer
    SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
    Date Cleared
    2009-06-12

    (71 days)

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

    SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical. The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1