Medex BF13
Medex BF13 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K841882 on 5 Jun 1984 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688511973), 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 | Number10351688511973 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK841882 | Date5 Jun 1984 | StatusActive |
Official records
- AccessGUDID record 10351688511973
- FDA 510(k) database K841882
Across registries
- FDA 510(k) K841882 decided 5 Jun 1984 Active
- FDA GUDID UDI-DI 10351688511973 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K841882
- Listed FDA GUDID 10351688511973
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medex
- Generic name
- Electric infusion pump administration set, single-use
- Model / reference
- BF13
- Primary DI / UDI-DI
- 10351688511973
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Electric infusion pump administration set, single-use
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
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