RIVERSIDE, Calif.--(BUSINESS WIRE)--PCI, a global leader in the design and manufacture of on-site gas separation systems, has received FDA 510(k) clearance to market their oxygen generators (known as deployable oxygen concentrator systems, or DOCS) as medical devices.
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
Hospitals in the U.S. are becoming more aware of the need to upgrade their disaster preparedness programs, which requires that they be self-sufficient for a 72-hour period. The trend to more disaster preparedness is pushing hospitals to take a closer look at on-site oxygen generation for either a backup or as the major supply for their medical oxygen; both for feeding directly into a central supply system and for filling cylinders.
Medical devices are regulated by the Food and Drug Administration (FDA) in the United States or by similar regulatory government agencies across the world to protect patients and ensure their safety. According to United States regulation 21 CFR 868.5440, the FDA considers equipment that can simultaneously fill cylinders and provide oxygen directly to the hospital to be a class II device and therefore requires FDA marketing clearance. PCI has received such clearance for its on-site oxygen generators.
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.
“We are very excited to provide, for the first time, an FDA approved, reliable and affordable alternative for backup oxygen. A solution that will greatly benefit disaster preparedness agencies responsible for large mobile field hospitals or hospitals in remote locations." – Soeren Schmitz, VP and GM of the Oxygen Solutions division at PCI.
PCI is the only supplier that currently has FDA clearance for marketing and sale of United States Pharmacopeia (USP) 93 Medical Oxygen generators over 40 liters per minute for use outside of the military. PCI can also deliver complete ISO 10083 compliant oxygen supply systems including redundant oxygen generators, cylinder backup systems, and logic control systems.
About PCI – Pacific Consolidated Industries, LLC was founded in 1984 to manufacture cryogenic air separation devices for operation in extreme and remote environments. Since then, PCI has continually expanded its technology platforms to include membrane and adsorption (VSA) technology. PCI manufactures ruggedized on-site liquid and gaseous oxygen and nitrogen generators for a variety of markets; including Military, Medical, Water & Wastewater Treatment, Industrial, and Oil & Gas markets. We have built thousands of systems that are actively operating and supported in over 25 countries worldwide. PCI's corporate headquarters is located in Riverside, California. For more information about our products and services, please visit our website at www.pcigases.com.