Identity
- Trade Name
- MIXJECT FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- Mixject 13mm w/30G needle T/N FDA UDI
- Model / Reference
- 970133 FDA UDI
- Description
- Mixject 13mm w/30G needle T/N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290108241037 FDA UDI
- 510(k) Number
- K963583 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Medication transfer set 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
No
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 set
Mixject 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
K963583 also covers:
- MIXJECT — WEST PHARMA. SERVICES IL, . LTD
- MIXJECT — WEST PHARMA. SERVICES IL, . LTD
- Vial Adapter 13mm — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor — 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 663678de-e45b-48a5-abc3-8bf8bd324a15 34 fields · synced May 30, 2026