Autopen - 1 unit AN3810

GUDID 00384703810013

OWEN MUMFORD LIMITED

Cartridge-accepting autoinjector, mechanical

Primary Device ID	00384703810013
NIH Device Record Key	674f1404-72a2-4287-8091-0768751f76f1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Autopen - 1 unit
Version Model Number	AN3810
Catalog Number	AN3810
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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
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
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
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	165 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 Millimeter
Width	15 Millimeter
Length	165 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
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
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
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	00384703810013 [Primary]
GS1	00384703810037 [Package] Package: Case [100 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983974

FDA Product Code

FMF	Syringe, Piston

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