21 CFR 868.5770 — Device, Fixation, Tracheal Tube
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5770
Identification
A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.
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 |
|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | 1 | 47 | |
| OGI | Nasal Endotracheal Tube Holder Kit | 1 | 0 |
