H9389BTS
by Baxter Corporation Englewood
H9389BTS is a Class II device made by Baxter Corporation Englewood, cleared under FDA 510(k) K872743 on 9 Oct 1987 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00085412481401), 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 | Number00085412481401 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK872743 | Date9 Oct 1987 | StatusActive |
Official records
- AccessGUDID record 00085412481401
- FDA 510(k) database K872743
Across registries
- FDA 510(k) K872743 decided 9 Oct 1987 Active
- FDA GUDID UDI-DI 00085412481401 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K872743
- Listed FDA GUDID 00085412481401
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Fluid transfer set, general-purpose
- Model / Ref / Catalog
- H9389BTS
- Primary DI / UDI-DI
- 00085412481401
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Fluid transfer set, general-purpose
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Fluid transfer set, general-purpose.