DEVICE: Autoject 2 - Fixed Needle (00384701300011)

Device Identifier (DI) Information

Autoject 2 - Fixed Needle
AJ1300
In Commercial Distribution
AJ1300
OWEN MUMFORD LIMITED
00384701300011
GS1

1
217266915 *Terms of Use
Non-sterile reusable autoinjector device for the injection of FDA-approved drugs from fixed needle syringes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
KZH Introducer, Syringe Needle
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K945660 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Width: 25 Millimeter
Length: 210 Millimeter
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Device Record Status

ca83f17e-f353-4664-8756-b745afe506a3
July 06, 2018
3
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00384701300035 50 00384701300011 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+441993812021
info@owenmumford.co.uk
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