AOJ

GUDID 06972040110152

Shenzhen AOJ Medical Technology Co., Ltd

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

Primary Device ID	06972040110152
NIH Device Record Key	a20ac7fd-abd4-4c8d-a552-b4d701392a40
Commercial Distribution Status	In Commercial Distribution
Brand Name	AOJ
Version Model Number	AOJ-20A
Company DUNS	554409093
Company Name	Shenzhen AOJ Medical Technology 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	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972040110152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182133

FDA Product Code

FLL	Thermometer, Electronic, Clinical

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	2020-04-27
Device Publish Date	2019-10-16

On-Brand Devices [AOJ]

06972040110015	AOJ-20A
06972040110206	AOJ-20F
06972040110183	AOJ-20E
06972040110169	AOJ-20B
06972040110152	AOJ-20A
06972040110039	AOJ-20B