CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 868—ANESTHESIOLOGY DEVICES > SUBPART F—Therapeutic Devices (§868.5090 to §868.5995) > 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).