CombiSet 03-2696-7
by Fresenius Medical Care Holdings, Inc.
CombiSet 03-2696-7 is a Class II device made by Fresenius Medical Care Holdings, Inc., cleared under FDA 510(k) K000451 on 9 May 2000 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00840861100286), 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 | Number00840861100286 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000451 | Date9 May 2000 | StatusActive |
Official records
- AccessGUDID record 00840861100286
- FDA 510(k) database K000451
Across registries
- FDA 510(k) K000451 decided 9 May 2000 Active
- FDA GUDID UDI-DI 00840861100286 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K000451
- Listed FDA GUDID 00840861100286
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CombiSet
- Generic name
- Haemodialysis blood tubing set, single-use
- Model / Ref / Catalog
- 03-2696-7
- Primary DI / UDI-DI
- 00840861100286
- 510(k) Number
- FDA product code
- FJK
- GMDN term
- Haemodialysis blood tubing set, single-use
- Device class
- Class II
- Regulation number
- 876.5820
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 185 Milliliter
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