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Autoject 2

FDA UDI

Class II (US FDA UDI)

by Owen Mumford Limited

Identity

Trade Name
Autoject 2 FDA UDI
Generic Name
Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Device Name
Fixed needle, non-sterile reusable injector. FDA UDI
Model / Reference
AJ1300 FDA UDI
Description
Fixed needle, non-sterile reusable injector. FDA UDI

Identifiers

Catalog Number
AJ1300 FDA UDI
Primary DI / UDI-DI
00384701300011 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 UDI
Length — 210 Millimeter FDA UDI

Category: Syringe-loaded medication/vaccine injector, manual, professional

Autoject 2 by Owen Mumford Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe-loaded medication/vaccine injector, manual, professional.

Cleared under the same submission

K945660 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owen Mumford Limited

Sources (1)

  • FDA UDI ca83f17e-f353-4664-8756-b745afe506a3 38 fields · synced Jun 7, 2026