Avanos 35114
Avanos 35114 is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K080821 on 22 Apr 2008 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 00609038351148), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00609038351148 | Date1 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080821 | Date22 Apr 2008 | StatusActive |
Official records
- AccessGUDID record 00609038351148
- FDA 510(k) database K080821
Across registries
- FDA 510(k) K080821 decided 22 Apr 2008 Active
- FDA GUDID UDI-DI 00609038351148 listed 1 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K080821
- Listed FDA GUDID 00609038351148
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- Withdrawn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
- 35114
- Primary DI / UDI-DI
- 00609038351148
- 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 — 6.3 Millimeter
Similar devices in this category
Other devices filed under Basic endotracheal tube, single-use.
- PLAIN ORAL/NASAL(ON)ET TUBE ID 3.5 MAGILL - STERILE 038-961-035MU by FLEXICARE MEDICAL LIMITED
- VENTISEAL ORAL/NASAL(ON)ET TUBE ID 2.5 - STERILE -USA 038-971-025U by FLEXICARE MEDICAL LIMITED
- RUSCH IPN041460 111782-000075 by TELEFLEX INCORPORATED
- Endotracheal Tubes ETT-P10-20 by Tianjin Medis Medical Device Co., Ltd.
- RUSCH IPN041634 112682075 by TELEFLEX INCORPORATED