AFAC

GUDID 06972040110114

Shenzhen AOJ Medical Technology Co., Ltd

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

• 16972040110678 - DrBash: 2024-09-06
• 16972040110715 - DrBash: 2024-09-06
• 06972040112514 - Medisana: 2024-05-31
• 06972040112538 - Medisana: 2024-05-31
• 06972040112545 - Medisana: 2024-05-31
• 06972040112552 - Medisana: 2024-05-31
• 06972040112569 - Medisana: 2024-05-31
• 06972040112576 - Medisana: 2024-05-31