YUWELL Infrared ear thermometer

GUDID 06933257922082

The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.

Infrared patient thermometer, ear

• Primary Device ID: 06933257922082
• NIH Device Record Key: c210b64b-b669-48a0-8665-658657699d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Infrared ear thermometer
• Version Model Number: YHT101
• 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: 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	06933257922082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203583

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: 2024-01-11
• Device Publish Date: 2024-01-03

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• 06933257922082 - YUWELL Infrared ear thermometer: 2024-01-11 The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body tempera
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