AccessGUDID - DEVICE: Autoject EI (00384701310010)

GUDID

Device Identifier (DI) Information

Brand Name: Autoject EI
Version or Model: AJ1310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AJ1310
Company Name: OWEN MUMFORD LIMITED

Primary DI Number: 00384701310010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217266915 *Terms of Use

Device Description: Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

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Product Code	Product Code Name
KZH	Introducer, Syringe Needle

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Width: 25 Millimeter
Length: 210 Millimeter

Device Record Status

Public Device Record Key: eb1114d8-ac6a-4e80-87cd-b2715e244a4d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016