DEVICE: Autoject EI (00384701310010)
Device Identifier (DI) Information
Autoject EI
AJ1310
In Commercial Distribution
AJ1310
OWEN MUMFORD LIMITED
AJ1310
In Commercial Distribution
AJ1310
OWEN MUMFORD LIMITED
Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Syringe-loaded injector, manual, professional | A hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) or subcutaneously. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KZH | Introducer, Syringe Needle |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K945660 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Width: 25 Millimeter |
Length: 210 Millimeter |
Device Record Status
eb1114d8-ac6a-4e80-87cd-b2715e244a4d
July 06, 2018
3
September 19, 2016
July 06, 2018
3
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00384701310034 | 50 | 00384701310010 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441993812021
info@owenmumford.co.uk
info@owenmumford.co.uk