Avanos 35113
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
The AVANOS pediatric endotracheal tube (PET) is a single-use, radiopaque device designed for the insertion of an unobstructed airway into the trachea during anesthesia, resuscitation, and other medical procedures. It features a built-in pilot balloon for cuff pressure monitoring and a distal inflatable cuff to seal against the tracheal wall.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00609038351131 | Date1 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080821 | Date22 Apr 2008 | StatusActive |
Official records
- AccessGUDID record 00609038351131
- FDA 510(k) database K080821
Across registries
- FDA 510(k) K080821 decided 22 Apr 2008 Active
- FDA GUDID UDI-DI 00609038351131 listed 1 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K080821
- Listed FDA GUDID 00609038351131
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Avanos
- Generic name
- Basic endotracheal tube, single-use
- Model / Ref / Catalog
- 35113
- Primary DI / UDI-DI
- 00609038351131
- FDA product code
- BTR
- GMDN term
- Basic endotracheal tube, single-use
- Device class
- Class II
- Regulation number
- 868.5730
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 5.6 Millimeter
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