21 CFR 868.5450 — Humidifier, Respiratory Gas, (Direct Patient Interface)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5450
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 221 | |
| OBN | Humidifier, Respiratory, Mask (Direct Patient Interface) | 2 | 1 | 3rd Party |
| OGG | Humidifier Nebulizer Kit | 2 | 0 |
