Kbmed ES3
by KB Medical (group), Inc. 4 variants
Kbmed ES3 is an ENFit oral/enteral syringe (FDA Class II; FDA product code PNR, Enteral Syringes With Enteral Specific Connectors) made by KB Medical (group), Inc., cleared under FDA 510(k) K182649 on 9 Nov 2018 and listed in FDA GUDID since 21 May 2025 (UDI-DI 00850016172020), 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 | Number00850016172020 | Date21 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182649 | Date9 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 00850016172020
- FDA 510(k) database K182649
Across registries
- FDA 510(k) K182649 decided 9 Nov 2018 Active
- FDA GUDID UDI-DI 00850016172020 listed 21 May 2025 Listed
Timeline
- Cleared FDA 510(k) K182649
- Listed FDA GUDID 00850016172020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kbmed
- Generic name
- ENFit oral/enteral syringe, single-use
- Model / reference
- ES3
- Primary DI / UDI-DI
- 00850016172020
- 510(k) Number
- FDA product code
- PNR
- GMDN term
- ENFit oral/enteral syringe, single-use
- Device class
- Class II
- Regulation number
- 876.5980
- GUDID distribution status
- In Commercial Distribution
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