21 C.F.R. § 870.4300
Cardiopulmonary bypass gas control unit.
Cite as 21 C.F.R. § 870.4300 (2026)
(a) Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas. (b) Classification. Class II (performance standards).