SimpliCare

GUDID 06953775661355

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, ear/skin

• Primary Device ID: 06953775661355
• NIH Device Record Key: d746c9ea-2ab8-4f3b-8a85-2d0f1000641a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimpliCare
• Version Model Number: AET-R842
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953775661355 [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: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [SimpliCare]

• 06953775661379: AES-U181
• 06953775661362: AES-U382
• 06953775661355: AET-R842