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ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.

The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier. The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port. Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam. Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.