21 CFR 868.5730 — Tube, Tracheal (W/Wo Connector)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5730
Identification
A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 240 | Life-Sustaining |
| LNZ | Changer, Tube, Endotracheal | 2 | 2 | 3rd Party |
| NMA | Tube, Tracheal, Reprocessed | 2 | 0 | Life-Sustaining |
| OQU | Airway Monitoring System | 2 | 3 |
