CocoBear Non-contact Infrared Thermometer

GUDID 06953775612166

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin

• Primary Device ID: 06953775612166
• NIH Device Record Key: b959e12b-023c-4c4d-a7f3-305f6d985826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CocoBear Non-contact Infrared Thermometer
• Version Model Number: AET-R1B1-B
• 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	06953775612166 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-04
• Device Publish Date: 2019-08-26

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

• 06953775658584: AET-R171-D
• 06953775612166: AET-R1B1-B