Jelco 96005
Jelco 96005 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K923090 on 1 Sep 1992 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 00351688065592), 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 | Number00351688065592 | Date9 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923090 | Date1 Sep 1992 | StatusActive |
Official records
- AccessGUDID record 00351688065592
- FDA 510(k) database K923090
Across registries
- FDA 510(k) K923090 decided 1 Sep 1992 Active
- FDA GUDID UDI-DI 00351688065592 listed 9 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K923090
- Listed FDA GUDID 00351688065592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Jelco
- Generic name
- Blood collection tube holder, single-use
- Model / reference
- 96005
- Primary DI / UDI-DI
- 00351688065592
- 510(k) Number
- FDA product code
- JKA
- GMDN term
- Blood collection tube holder, single-use
- Device class
- Class II
- Regulation number
- 862.1675
- GUDID distribution status
- In Commercial Distribution
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