PCI of Riverside, California won FDA 510(k) clearance for the company’s line of oxygen generators to now be formally labeled as medical devices. The approval includes three stationary generators, one mobile unit that can sit on a trailer, and one “expeditionary deployable” light weight unit designed for military medicine and disaster applications.
Based on existing technology used in its military medical oxygen generators, PCI has developed a commercial line of on-site oxygen generators, known as DOCS. To produce oxygen, these systems utilize a proprietary Vacuum Swing Adsorption (VSA) process. This technology offers the lowest operating cost and most reliable oxygen generator in its class, with outputs ranging from 66 liters per minute (280 lbs per day) to 500 liters per minute (1 ton per day) at 93% +/- 3% purity. These systems are built to be light weight, compact, and turn-key. Installation time is measured in hours and not days.
These medical devices generate and deliver USP grade 93% ± 3% oxygen to be used for the following:Disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available Hospital backup systems In local emergencies where disaster has rendered the primary oxygen supply unusable Fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use OR by trained military personnel in peacetime or wartime support of the Armed Forces
Press release: PCI RECEIVES FDA 510(k) CLEARANCE FOR ON-SITE OXYGEN GENERATORS…
Product page: PCI oxygen generators…