Breethe, Inc.

Breethe, Inc. specializes in cardiopulmonary support systems. Its primary products include non-roller cardiopulmonary bypass systems and extracorporeal membrane oxygenators, such as the Abiomed Breethe OXY-1 System. These devices are engineered to temporarily replace or assist the heart and lungs during complex cardiac surgeries or critical care scenarios, ensuring continuous blood oxygenation and circulation.

Breethe, Inc. is headquartered in the United States, meaning its devices fall under FDA jurisdiction. The FDA classifies these products as Class II, indicating they pose moderate risk and require special controls to ensure safety and effectiveness. This classification influences how the devices are regulated, tested, and listed in databases like the FDA’s Unique Device Identifier (UDI) system.

Breethe, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to identify medical devices throughout their distribution and use, ensuring traceability and compliance with FDA requirements. This listing helps healthcare providers and regulators verify the device’s identity and regulatory status.

Breethe, Inc.’s devices, such as the Abiomed Breethe OXY-1 System, are classified as Class II under FDA regulations. This classification is based on the device’s intended use and risk level—specifically, its role in supporting critical circulatory and respiratory functions during high-risk procedures. Class II devices require premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet safety and performance standards.