21 CFR 868.5375 — Condenser, Heat And Moisture (Artificial Nose)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5375
Identification
A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 73 |
