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510(k) Data Aggregation

    K Number
    K153363
    Device Name
    Red2Green Reusable Sharps Container
    Manufacturer
    TRIUMVIRATE ENVIRONMENTAL, INC.
    Date Cleared
    2016-07-26

    (249 days)

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

    TRIUMVIRATE ENVIRONMENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Red2Green Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
    Device Description
    Red2Green Reusable Sharps Containers are reusable sharps containers designed for disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes.
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