Portex 4909CS-21
Portex 4909CS-21 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K110053 on 14 Sep 2012 and listed in FDA GUDID since 13 Dec 2016 (UDI-DI 20351688068436), 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 | Number20351688068436 | Date13 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110053 | Date14 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 20351688068436
- FDA 510(k) database K110053
Across registries
- FDA 510(k) K110053 decided 14 Sep 2012 Active
- FDA GUDID UDI-DI 20351688068436 listed 13 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K110053
- Listed FDA GUDID 20351688068436
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Portex
- Generic name
- Epidural anaesthesia set, non-medicated
- Model / reference
- 4909CS-21
- Primary DI / UDI-DI
- 20351688068436
- 510(k) Number
- FDA product code
- CAZ
- GMDN term
- Epidural anaesthesia set, non-medicated
- Device class
- Class II
- Regulation number
- 868.5140
- GUDID distribution status
- In Commercial Distribution
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