Autokeeper

GUDID 18809445831502

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

• Primary Device ID: 18809445831502
• NIH Device Record Key: cbe1cd12-6ded-4d6b-95e1-f28318ccd8ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autokeeper
• Version Model Number: Safety Pen Needle 34G x 4mm 100PCS
• Company DUNS: 689719789
• Company Name: MEDEXEL CO.,LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Length: 4 Millimeter
• Needle Gauge: 29 Gauge
• Length: 4 Millimeter
• Needle Gauge: 29 Gauge
• Length: 4 Millimeter
• Needle Gauge: 29 Gauge
• Length: 4 Millimeter
• Needle Gauge: 29 Gauge

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809445831505 [Primary]
GS1	18809445831502 [Package]; Contains: 08809445831505; Package: case [10 Units]; In Commercial Distribution
GS1	28809445831509 [Package]; Package: master case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172095

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Autokeeper]

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