BH Supplies BH13012
BH Supplies BH13012 is a Class II device made by Anrel Distribution LLC, cleared under FDA 510(k) K152808 on 25 Mar 2016 and listed in FDA GUDID since 26 Jul 2023 (UDI-DI 00857682008646), 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 | Number00857682008646 | Date26 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152808 | Date25 Mar 2016 | StatusActive |
Official records
- AccessGUDID record 00857682008646
- FDA 510(k) database K152808
Across registries
- FDA 510(k) K152808 decided 25 Mar 2016 Active
- FDA GUDID UDI-DI 00857682008646 listed 26 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K152808
- Listed FDA GUDID 00857682008646
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BH Supplies
- Generic name
- Insulin syringe/needle, basic
- Model / reference
- BH13012
- Primary DI / UDI-DI
- 00857682008646
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Insulin syringe/needle, basic
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
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