Ampmed Non-contact Infrared Thermometer

GUDID 06953775658416

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin

• Primary Device ID: 06953775658416
• NIH Device Record Key: 121bc92d-dade-4dc0-a7c4-c0367ce1cd0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ampmed Non-contact Infrared Thermometer
• Version Model Number: AET-R1D2-D
• 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	06953775658416 [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: 2020-08-17
• Device Publish Date: 2020-08-07

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

• 06953775658386: AET-R1D1-G
• 06953775658416: AET-R1D2-D
• 06953775658553: AET-R1F1-J
• 06953775658720: AET-R1D2-F