FDA clears PCI's on-site oxygen generators
This article was originally published in Clinica
Executive Summary
Oxygen generators developed by Riverside, California-based gas separation specialist PCI have received US 510(k) clearance. The devices, known as deployable oxygen concentrator systems, or DOCS, generate and deliver 93%-pure oxygen. They can now be used: in disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available; as hospital backup systems; in local emergencies where the primary oxygen supply has been rendered unusable; to fill high-pressure oxygen cylinders for use in remote locations or for ambulatory patient use; or by military personnel in peacetime or wartime support of the Armed Forces. PCI is the only firm that currently has FDA clearance for sale of US Pharmacopeia (USP) 93 Medical Oxygen generators with an output of over 40 litres per minute for use outside of the military.