Autokeeper

FDA UDI

Class II (US FDA UDI)

by Medexel Co., Ltd.

Identity

Trade Name: Autokeeper FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Safety Pen Needle 31G x 8mm 100PCS FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809445831406 FDA UDI
510(k) Number: K172095 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 4 Millimeter FDA UDI
Needle Gauge — 29 Gauge FDA UDI

Category: Hypodermic needle, single-use

Autokeeper by Medexel Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypodermic needle, single-use.

Monoject — Cardinalhealth · Class II
Pinpoint GT — Bard Access Systems, Inc. · Class II
Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
Comfort EZ Pro — S.D.I. USA, INC. · Class II

Cleared under the same submission

K172095 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medexel Co., Ltd.

Sources (1)

FDA UDI 8bc09b3b-f692-4d68-b901-d0c593ba3136 36 fields · synced Jun 8, 2026