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510(k) Data Aggregation

    K Number
    K192382
    Device Name
    CapKlenZ
    Manufacturer
    Star Mountain Medical, Inc.
    Date Cleared
    2020-04-20

    (234 days)

    Product Code
    QBP
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Star Mountain Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.
    Device Description
    CapKlenZ consists of a solid reservoir made of polyethylene, which contains an absorbent material and 70% isopropyl alcohol (70% IPA). The opening of the reservoir is mechanically attached to a threaded membrane made of non-DEHP, non-latex elastomer, which lays in the internal geometry of the reservoir, this membrane is intended to be threaded to a needleless port connector and adapt to its shape. The reservoir and its contents are sealed with an extrusion laminated composite of polyester, polyethylene, aluminum foil, and a peelable sealant, which has to be removed before use. Once the needleless port connector is threaded, the shape and elasticity of the threaded membrane, isolates the proximal end of the needleless port connector within the interior of the reservoir along with the absorbent material and 70% IPA. When the needleless port connector is threaded into the membrane, the circular movement of the connector scrubs its tip against the absorbent material and exposes it to 70% IPA in order to disinfect it.
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