PCI medical devices generate and deliver Oxygen 93% +/- 3% gas quality in compliance with both the American1 and Europea2 Pharmacopeia monographs for Oxygen 93. Models can be ordered in US FDA3, China FDA (CFDA), or European4 compliant configurations, which also meet the critical requirements for ISO 7396-1:2016 medical gas pipeline system. All units are built to ISO 9001 and ISO 13485 quality standards.

1. United States Pharmacopoeia Monograph.
2. 93% Oxygen Monograph: European Pharmacopeia, Supplement 7.1.
3. FDA 510(K) Clearance.
4. CE Certified and Labelled in accordance with Council Directive 93/42 EEC Concerning Medical Devices (Class IIB); 2006/42 EC Machinery Directive; 97/23/EEC Pressure Equipment Directive (PED) and 2006/95/EC, Low Voltage Electrical Equipment Directive (LVD)