§868.5320. Reservoir bag. — Inbound Citations
21 C.F.R. § 868.5320
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 868.5320 as a whole
-
(a) An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (§ 868.5320), oxygen cannulas (§ 868.5340), masks (§ 868.5550), valves (§ 868.5870), resuscitation bags (§ 868.5915), and/or tubing (§ 868.5925).