KANG ZE INDUSTRIAL CO., LTD

Address:6th Floor, 6# Building, 10# Lane,Dongguan Guangdong,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thermometer, Clinical Mercury (FLK) (3) Thermometer, Electronic, Clinical (FLL) (3)

Premarket Exempt

Clear

Disposable Thermometer Cover and Sheaths - 06972543480103 Catalog Number :

Device Description : The Disposable Thermometer Covers and Sheaths are intended for use as barriers b The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

Device Class :

Duns Number: 542345014

Premarket Exempt : No

Product Code : FLK, FLL

Prescription Use : No

Device Count : 5000

Disposable Thermometer Cover and Sheaths - 06972543480110 Catalog Number :

Device Class :

Duns Number: 542345014

Premarket Exempt : No

Product Code : FLK, FLL

Prescription Use : No

Device Count : 21600

Disposable Thermometer Cover and Sheaths - 06972543480127 Catalog Number :

Device Class :

Duns Number: 542345014

Premarket Exempt : No

Product Code : FLK, FLL

Prescription Use : No

Device Count : 30000

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