Infrared Thermometer

GUDID 06972901150204

Shenzhen Sonida Digital Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06972901150204
• NIH Device Record Key: a8fc887e-581b-4385-93ee-a4c393d8acae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Thermometer
• Version Model Number: HT-103
• Company DUNS: 420171574
• Company Name: Shenzhen Sonida Digital Technology Co., Ltd.
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972901150204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202440

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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [Infrared Thermometer]

• 06972901150211: HT-104
• 06972901150204: HT-103
• 06972901150198: HT-102
• 06972901150006: HT-101