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510(k) Data Aggregation

    K Number
    K990936
    Device Name
    THE VAULT
    Date Cleared
    1999-05-18

    (60 days)

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

    STIK STOPPERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT's in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.
    Device Description
    The VAULT is a single-use , disposable , non-sterile, sharps transport container intended to be used in areas where larger sharps containers are not conveniently accessible, normally in the field use in paramedic and EMT jump kits. The Vaults design allows for easy one handed use by the EMT. Its function is to be available for portable sharps containment and as a alternative to using non-sharps containers or resheathing a needle with its original protective cover. The VAULT is a 1.5x 5 inch box designed to set horizontally in a jump kit. The lid is designed to remain open until use and then permanently close for transportation of the contaminated sharps for safe disposal. Each box is labeled with a biohazard label. The VAULT is also a bright red color to meet OSHA standards for warning of biohazard danger.
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