FANMI Infrared Thermometer

GUDID 06953775660853

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, ear

• Primary Device ID: 06953775660853
• NIH Device Record Key: 513dc3c5-eddf-486a-88d4-844a1acd5fef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FANMI Infrared Thermometer
• Version Model Number: AET-R151
• Company DUNS: 548040741
• Company Name: Alicn Medical Shenzhen, Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06953775660853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210564

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by Alicn Medical Shenzhen, Inc.

• 06953775660853 - FANMI Infrared Thermometer: 2025-04-08
• 06953775660853 - FANMI Infrared Thermometer: 2025-04-08
• 06953775660457 - BESTEK Arm Blood Pressure Monitor: 2024-10-29
• 06953775609203 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775609210 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775609227 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775633345 - BBLOVE Arm Blood Pressure Monitor: 2024-07-30
• 06953775660297 - ERDPAA Arm Blood Pressure Monitor: 2024-07-15
• 06953775660105 - ERDPAA Arm Blood Pressure Monitor: 2024-04-19