AFAC

GUDID 06972040110114

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: 06972040110114
• NIH Device Record Key: dbb3b81a-fd4e-46f5-8a58-35d579dd1ef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFAC
• Version Model Number: IT-D1
• 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	06972040110114 [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

Devices Manufactured by Shenzhen AOJ Medical Technology Co., Ltd

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• 06972040110817 - NA: 2023-04-03
• 06972040111456 - fridababy: 2022-11-08
• 06972040111432 - fridababy: 2022-10-26
• 06972040111166 - ANMEATE: 2022-03-28
• 06972040111067 - MediBio: 2022-03-24
• 06972040110794 - Electronic Blood Pressure Monitor: 2021-11-08 The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate