CFR › Title 21 › Part 870 › §870.425021 CFR §870.4250Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗Copy link(a)Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)Classification. Class II (performance standards).