Autokeeper

GUDID 18809445831373

Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper.

MEDEXEL CO.,LTD.

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use
Primary Device ID18809445831373
NIH Device Record Key9d866163-c055-4a64-ac80-fc6013b9dbeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutokeeper
Version Model NumberSafety Pen Needle 31G x 4mm 100PCS
Company DUNS689719789
Company NameMEDEXEL CO.,LTD.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Length4 Millimeter
Needle Gauge29 Gauge
Length4 Millimeter
Needle Gauge29 Gauge
Length4 Millimeter
Needle Gauge29 Gauge
Length4 Millimeter
Needle Gauge29 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809445831376 [Primary]
GS108809445831376 [Primary]
GS108809445831376 [Primary]
GS108809445831376 [Primary]
GS118809445831373 [Package]
Contains: 08809445831376
Package: case [4 Units]
In Commercial Distribution
GS118809445831373 [Package]
Contains: 08809445831376
Package: case [4 Units]
In Commercial Distribution
GS118809445831373 [Package]
Contains: 08809445831376
Package: case [4 Units]
In Commercial Distribution
GS118809445831373 [Package]
Contains: 08809445831376
Package: case [4 Units]
In Commercial Distribution
GS128809445831370 [Package]
Package: master case [10 Units]
In Commercial Distribution
GS128809445831370 [Package]
Package: master case [10 Units]
In Commercial Distribution
GS128809445831370 [Package]
Package: master case [10 Units]
In Commercial Distribution
GS128809445831370 [Package]
Package: master case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Autokeeper]

18809445831533Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831526Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831519Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831502Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831496Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831489Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831472Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831465Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831458Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831441Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831434Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831410Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831403Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831397Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831380Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831373Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831366Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831359Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831342Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831335Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831328Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831311Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
18809445831304Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in
28809445831295Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in

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