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 ID06933257922747
NIH Device Record Keyc8f5951f-bf60-49f1-9c34-c9499ccbfb6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameYUWELL Infrared Thermometer
Version Model NumberYT-1
Company DUNS528704000
Company NameJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106933257922747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-30

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

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