Autoject EI AJ1310

GUDID 00384701310010

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

OWEN MUMFORD LIMITED

Syringe-loaded injector, manual, professional

• Primary Device ID: 00384701310010
• NIH Device Record Key: eb1114d8-ac6a-4e80-87cd-b2715e244a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoject EI
• Version Model Number: AJ1310
• Catalog Number: AJ1310
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk
• Phone: +441993812021
• Email: info@owenmumford.co.uk

Device Dimensions

• Length: 210 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter
• Width: 25 Millimeter
• Length: 210 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701310010 [Primary]
GS1	00384701310034 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945660

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by OWEN MUMFORD LIMITED

• 00384701402036 - Unistik Touch: 2023-04-07 Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
• 00384701015038 - Unistik: 2023-02-15 Unistik Safety Lancet Economy - 21G
• 00384701027024 - Unistik 3: 2023-02-15 Unistik 3 Safety Lancet Gentle - 30G
• 00384701614033 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm
• 00384701634031 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 25G x 1.6mm
• 00384701644030 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 28G x 1.2mm
• 00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm: 2021-04-12 Sterile, single use safety lancet
• 00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm: 2021-04-12 Sterile, single use safety lancet