MEDRACHEL Non-contact Infrared Thermometer

GUDID 06953775600170

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin

• Primary Device ID: 06953775600170
• NIH Device Record Key: b59c727e-01fb-480a-992e-9e86fa8ac268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRACHEL Non-contact Infrared Thermometer
• Version Model Number: AET-R1D1-E
• 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	06953775600170 [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: 2020-07-23
• Device Publish Date: 2020-07-15

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

• 06953775600170: AET-R1D1-E
• 06953775600163: AET-R1B1-M