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§ 868.5450 Respiratory gas humidifier.

21 CFR 868.5450

Citation21 CFR 868.5450
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 868.5450 Respiratory gas humidifier.

(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).