Codonics SLS500i Operating Software 2.1.3
Codonics SLS500i Operating Software 2.1.3 is a Class II device made by Codonics Inc., cleared under FDA 510(k) K101439 on 7 Feb 2011 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 00814905020021), active as of 22 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 | Number00814905020021 | Date23 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101439 | Date7 Feb 2011 | StatusActive |
Official records
- AccessGUDID record 00814905020021
- FDA 510(k) database K101439
Across registries
- FDA 510(k) K101439 decided 7 Feb 2011 Active
- FDA GUDID UDI-DI 00814905020021 listed 23 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K101439
- Listed FDA GUDID 00814905020021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Codonics SLS500i Operating Software
- Generic name
- Parenteral-nutrition management software
- Model / reference
- 2.1.3
- Primary DI / UDI-DI
- 00814905020021
- 510(k) Number
- FDA product code
- BSZ
- GMDN term
- Parenteral-nutrition management software
- Device class
- Class II
- Regulation number
- 868.5160
- GUDID distribution status
- In Commercial Distribution
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