Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 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).