View all text of Subpart E [§ 870.4075 - § 870.4885]

§ 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).