Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082511
    Device Name
    MEDIGARD BLOOD COLLECTION DEVICE
    Manufacturer
    Date Cleared
    2009-01-16

    (140 days)

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

    MEDIGARD LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medical device to enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
    Device Description
    The Medigard Blood Collection Device Consists of two Parts 1) a blood collection tube holder and 2) an evacuated sharps collection tube Netther part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures The device is intended to be used to provide a safe and reliable method of collection of blood samples from a patient using standard evacuated blood collection tubes The device is designed to prevent accidental needle stick injury At the end of the procedure, the needle is retracted into the Medigard evacuated sharps collection tube
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1