Identity
- Trade Name
- Autoject EI FDA UDI
- Generic Name
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
- Device Name
- Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes FDA UDI
- Model / Reference
- AJ1310 FDA UDI
- Description
- Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes FDA UDI
Identifiers
- Catalog Number
- AJ1310 FDA UDI
- Primary DI / UDI-DI
- 00384701310010 FDA UDI
- 510(k) Number
- K945660 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 25 Millimeter FDA UDILength — 210 Millimeter FDA UDI
Category: Syringe-loaded medication/vaccine injector, manual, professional
Autoject EI by Owen Mumford Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945660 also covers:
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
- Owen Mumford Limited
Sources (1)
- FDA UDI eb1114d8-ac6a-4e80-87cd-b2715e244a4d 38 fields · synced May 30, 2026