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510(k) Data Aggregation

    K Number
    K052445
    Device Name
    DUOPROSS NEEDLE
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Date Cleared
    2005-12-05

    (89 days)

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

    DUOPROSS MEDITECH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
    Device Description
    The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide. The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard.
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    K Number
    K042500
    Device Name
    DUOPROSS SYRINGES
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Date Cleared
    2005-02-22

    (161 days)

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

    DUOPROSS MEDITECH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body. The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.
    Device Description
    The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations. Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe. The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber.
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