FANMI

GUDID 06953775661737

Black

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, ear

• Primary Device ID: 06953775661737
• NIH Device Record Key: e5e6149d-6835-4fc5-be7c-10c8de77aa45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FANMI
• 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	06953775661737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210564

FDA Product Code

• SDV: Clinical Electronic Thermometer

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: 2025-09-05
• Device Publish Date: 2025-08-28

Devices Manufactured by Alicn Medical Shenzhen, Inc.

• 06953775661737 - FANMI: 2025-09-05Black
• 06953775661737 - FANMI: 2025-09-05 Black
• 06953775661706 - BBLOVE: 2025-08-12
• 06953775661645 - huangirl: 2025-07-07
• 06953775661584 - AILIFEE: 2025-07-04
• 06953775661591 - AILIFEE: 2025-07-04
• 06953775661607 - AILIFEE: 2025-07-04
• 06953775661614 - AILIFEE: 2025-07-04
• 06953775661621 - AILIFEE: 2025-07-04