Identity
- Trade Name
- Mix2Vial Transfer Device FDA UDI
- Generic Name
- Medication transfer needle, filtering FDA UDI
- Device Name
- Mix2Vial 20/17mm W/5mic Filter SIL FDA UDI
- Model / Reference
- 8074208 FDA UDI
- Description
- Mix2Vial 20/17mm W/5mic Filter SIL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290108240399 FDA UDI
- 510(k) Number
- K031861 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Medication transfer needle, filtering FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Medication transfer needle, filtering
Mix2Vial Transfer Device by West Pharma. Services Il, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031861 also covers:
- Mix2Vial 20/20mm — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
- Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- West Pharma. Services Il, . Ltd
Sources (1)
- FDA UDI 0457db4f-e7b6-4a3e-9cb8-080a3d547acd 34 fields · synced Jun 8, 2026