21 CFR 868.5090 — Needle, Emergency Airway
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5090
Identification
An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BWC | Needle, Emergency Airway | 2 | 14 | 3rd Party, Life-Sustaining |
