21 CFR § 870.4300 - Cardiopulmonary bypass gas control unit.

§ 870.4300 Cardiopulmonary bypass gas control unit.

(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).