TRACOE vario REF 450-07
TRACOE vario REF 450-07 is a Class II device made by Tracoe medical GmbH, cleared under FDA 510(k) K203362 on 5 Aug 2021 and listed in FDA GUDID since 18 Oct 2015 (UDI-DI 04035324012282), 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 | FDA 510(k)SESE | NumberK203362 | Date5 Aug 2021 | StatusActive |
| United States | GUDID listing | Number04035324012282 | Date18 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 04035324012282
- FDA 510(k) database K203362
Across registries
- FDA 510(k) K203362 decided 5 Aug 2021 Active
- FDA GUDID UDI-DI 04035324012282 listed 18 Oct 2015 Listed
Timeline
- Listed FDA GUDID 04035324012282
- Cleared FDA 510(k) K203362
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TRACOE vario
- Generic name
- Tracheostomy tube, reinforced, non-customized, single-use
- Model / Ref / Catalog
- REF 450-07
- Primary DI / UDI-DI
- 04035324012282
- 510(k) Number
- FDA product code
- JOH
- GMDN term
- Tracheostomy tube, reinforced, non-customized, single-use
- Device class
- Class II
- Regulation number
- 868.5800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Lumen/Inner Diameter — 7.0 Millimeter