Autoject 2 - Fixed Needle AJ1300

GUDID 00384701300011

Non-sterile reusable autoinjector device for the injection of FDA-approved drugs from fixed needle syringes

OWEN MUMFORD LIMITED

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Primary Device ID00384701300011
NIH Device Record Keyca83f17e-f353-4664-8756-b745afe506a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoject 2 - Fixed Needle
Version Model NumberAJ1300
Catalog NumberAJ1300
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk

Device Dimensions

Length210 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter
Width25 Millimeter
Length210 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384701300011 [Primary]
GS100384701300035 [Package]
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZHIntroducer, Syringe Needle

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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