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510(k) Data Aggregation

    K Number
    K041941
    Device Name
    SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
    Manufacturer
    SAFE T MEDICAL DEVICES, LTD.
    Date Cleared
    2004-09-13

    (56 days)

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

    SAFE T MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The function of the Safe T Retractable Blood Collection Device is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needle stick injury.
    Device Description
    The Safe T Retractable Blood Collection Device is comprised of three components, a body, plunger and hub. The thread in the hub component matches that of all regular tube holders. The space within the holder is sufficient to fit all regular multi-sample needles after retraction. The device is supplied fully assembled, primed and ready for use, bulk packaged in polyethylene bags of 10 units. The device is non patient contacting and thus is sold non sterile.
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