21 C.F.R. § 868.5450

Respiratory gas humidifier.

Last amended: 2016Year: 2026Length: 48 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5450 (2026)

(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. (b) Classification. Class II (performance standards).
21 C.F.R. § 868.5450: Respiratory gas humidifier. | Justis AI