Code of Federal Regulations Title 21. Food and Drugs § 21.864.9205 Blood and plasma warming device

(1) Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

(2) Classification. Class II (performance standards).

(1) Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

(2) Classification. Class III (premarket approval).