Mixject 970133
by West Pharma. Services Il, . Ltd
Mixject 970133 is a Class II device made by West Pharma. Services Il, . Ltd, cleared under FDA 510(k) K963583 on 7 Oct 1996 and listed in FDA GUDID since 1 May 2016 (UDI-DI 07290108241037), 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 | Number07290108241037 | Date1 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK963583 | Date7 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 07290108241037
- FDA 510(k) database K963583
Across registries
- FDA 510(k) K963583 decided 7 Oct 1996 Active
- FDA GUDID UDI-DI 07290108241037 listed 1 May 2016 Listed
Timeline
- Cleared FDA 510(k) K963583
- Listed FDA GUDID 07290108241037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mixject
- Generic name
- Medication transfer set
- Model / reference
- 970133
- Primary DI / UDI-DI
- 07290108241037
- 510(k) Number
- FDA product code
- LHI
- GMDN term
- Medication transfer set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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