General Air Service and Supply

General Air Service and Supply specializes in producing clinical blood gas mixtures, which are carefully formulated gas blends. These mixtures are essential for calibrating and validating blood gas analyzers, ensuring accurate diagnostic results for patients. The focus is on precision and reliability in medical testing environments.

The company is headquartered in the United States, where it operates its manufacturing and distribution operations. This location aligns with regulatory requirements for device development and compliance.

General Air Service and Supply’s clinical blood gas mixtures are listed in the FDA’s 510(k) registry, a pathway used for Class II devices. This pathway demonstrates that the company’s products meet FDA requirements for safety and effectiveness through a premarket submission process.

The company’s clinical blood gas mixtures fall under FDA Class II classification, which applies to devices that pose moderate risk. This classification requires compliance with specific controls, including performance standards and post-market surveillance, to ensure patient safety and device functionality.