Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091474
    Device Name
    EASY.TOUCH INSULIN SYRINGE
    Date Cleared
    2009-07-09

    (52 days)

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

    MASTERS HEALTHCARE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Easy•Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.
    Device Description
    The Easy.Touch insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1