YUWELL Infrared Thermometer

GUDID 06933257922747

The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Infrared patient thermometer, skin

• Primary Device ID: 06933257922747
• NIH Device Record Key: c8f5951f-bf60-49f1-9c34-c9499ccbfb6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Infrared Thermometer
• Version Model Number: YT-1
• Company DUNS: 528704000
• Company Name: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	06933257922747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201864

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: 2024-07-08
• Device Publish Date: 2024-06-30

Devices Manufactured by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

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