BH Supplies BH1LS
BH Supplies BH1LS is a Class II device made by Anrel Distribution LLC, cleared under FDA 510(k) K132553 on 27 Feb 2014 and listed in FDA GUDID since 3 Nov 2023 (UDI-DI 00850053135156), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850053135156 | Date3 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132553 | Date27 Feb 2014 | StatusActive |
Official records
- AccessGUDID record 00850053135156
- FDA 510(k) database K132553
Across registries
- FDA 510(k) K132553 decided 27 Feb 2014 Active
- FDA GUDID UDI-DI 00850053135156 listed 3 Nov 2023 Listed
Recalls
-
- Completed Z-0478-2023
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Timeline
- Cleared FDA 510(k) K132553
- Recall initiated FDA recalls Z-0478-2023
- Listed FDA GUDID 00850053135156
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BH Supplies
- Generic name
- General-purpose syringe, single-use
- Model / reference
- BH1LS
- Primary DI / UDI-DI
- 00850053135156
- 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
Similar devices in this category
Other devices filed under General-purpose syringe, single-use.