FDA product code PMB
External Airway
Anesthesiology·Class 2·21 CFR 868.5105
US regulatory classifications
- US Product Code (FDA)
- PMBView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 868.5105View CFR Regulation →
- Medical specialty
- Anesthesiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
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About this record
External Airway is a medical device type in the Anesthesiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.