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 Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear 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

Devices Manufactured by Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.

• 06933257921849 - YUWELL Oxygen Concentrator: 2024-03-25 This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility a
• 16933257921853 - YUWELL Oxygen Concentrator: 2024-03-25 This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility a
• 06933257922082 - YUWELL Infrared ear thermometer: 2024-01-11The 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).
• 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
• 06933257916517 - Electronic Blood Pressure Monitor: 2021-11-23 The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject dev
• 06933257914063 - Electronic Blood Pressure Monitor: 2021-02-04 The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject dev