MixJect Transfer Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230464 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MixJect Transfer Device is a medical device classified as a Drug-Device Combination under the FDA’s nomenclature, designed for the safe and precise transfer of liquids between containers, particularly in pharmaceutical compounding. It facilitates the aseptic mixing or dispensing of medications, reducing contamination risk during preparation.
This device is supplied as a single-use, non-sterile component intended for use in hospital pharmacies or sterile compounding environments. It is compatible with standard pharmaceutical containers and requires no additional regulatory approval beyond its FDA 510(k) clearance and MDR compliance. Storage instructions specify protection from moisture and physical damage, with no MRI safety considerations noted.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230464 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
Sources (2)
- FDA 510(k) K230464 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026