OGI · Nasal Endotracheal Tube Holder Kit
Anesthesiology · 21 CFR 868.5770 · Class 1
Overview
| Product Code | OGI |
|---|---|
| Device Name | Nasal Endotracheal Tube Holder Kit |
| Regulation | 21 CFR 868.5770 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
