21 CFR 868.5740 — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5740
Identification
A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | 34 | Life-Sustaining |