Sinocare Non-contact Infrared Thermometer

GUDID 06953775658058

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin

• Primary Device ID: 06953775658058
• NIH Device Record Key: 35d0a949-81fb-44f2-ad6f-770bcd690b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinocare Non-contact Infrared Thermometer
• Version Model Number: AET-R161-C
• 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: false
• 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	06953775658058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180207

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: 2020-03-30
• Device Publish Date: 2020-03-21

On-Brand Devices [Sinocare Non-contact Infrared Thermometer]

• 06953775612203: AET-R1B1-E
• 06953775612258: blue
• 06953775658058: AET-R161-C
• 06953775658140: AET-R1D1-B
• 06953775658805: AET-R1D1-J