21 CFR § 868.5450 - Respiratory gas humidifier.

§ 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).