Baixin 5ML22GSLIP
by Anhui Kangda Medical Products Co., Ltd.
Baixin 5ML22GSLIP is a Class II device made by Anhui Kangda Medical Products Co., Ltd., cleared under FDA 510(k) K083686 on 2 Jul 2009 and listed in FDA GUDID since 22 Feb 2024 (UDI-DI 06936018501311), 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 | Number06936018501311 | Date22 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083686 | Date2 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 06936018501311
- FDA 510(k) database K083686
Across registries
- FDA 510(k) K083686 decided 2 Jul 2009 Active
- FDA GUDID UDI-DI 06936018501311 listed 22 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K083686
- Listed FDA GUDID 06936018501311
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Baixin
- Generic name
- General-purpose syringe/needle
- Model / reference
- 5ML22GSLIP
- Primary DI / UDI-DI
- 06936018501311
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- General-purpose syringe/needle
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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