CarePoint Precision 04-0003
CarePoint Precision 04-0003 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K124037 on 12 Sep 2013 and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00786227040356), 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 | Number00786227040356 | Date29 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK124037 | Date12 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 00786227040356
- FDA 510(k) database K124037
Across registries
- FDA 510(k) K124037 decided 12 Sep 2013 Active
- FDA GUDID UDI-DI 00786227040356 listed 29 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K124037
- Listed FDA GUDID 00786227040356
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CarePoint Precision
- Generic name
- General-purpose syringe, single-use
- Model / reference
- 04-0003
- Primary DI / UDI-DI
- 00786227040356
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- General-purpose syringe, single-use
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3 Milliliter
Similar devices in this category
Other devices filed under General-purpose syringe, single-use.