Autoject 2 - Removable Needle AJ1311

GUDID 00384701311017

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

OWEN MUMFORD LIMITED

Syringe-loaded injector, manual, professional
Primary Device ID00384701311017
NIH Device Record Key42b543ba-6fe9-479d-88d8-f5f1df8dfe9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoject 2 - Removable Needle
Version Model NumberAJ1311
Catalog NumberAJ1311
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

Length220 Millimeter
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 Millimeter
Width25 Micrometer
Length220 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
GS100384701311017 [Primary]
GS10384701311031 [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

Devices Manufactured by OWEN MUMFORD LIMITED

00384701402036 - Unistik Touch2023-04-07 Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
00384701015038 - Unistik 2023-02-15 Unistik Safety Lancet Economy - 21G
00384701027024 - Unistik 32023-02-15 Unistik 3 Safety Lancet Gentle - 30G
00384701614033 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm
00384701634031 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 25G x 1.6mm
00384701644030 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 28G x 1.2mm
00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm2021-04-12 Sterile, single use safety lancet
00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm2021-04-12 Sterile, single use safety lancet
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.