DANZ

GUDID 16970289035455

Infrared Body Thermometer

Hetaida Technology Co., Ltd

Infrared patient thermometer, skin
Primary Device ID16970289035455
NIH Device Record Keyae40f801-8b4a-481c-a7b9-30689e154ec6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDANZ
Version Model NumberH8228US
Company DUNS544474402
Company NameHetaida Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn
Phone+86076982658050
Emailtomchen@hetaida.com.cn

Device Dimensions

Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter
Height52 Centimeter
Width34 Centimeter
Length154 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS106970289035458 [Primary]
GS116970289035455 [Package]
Contains: 06970289035458
Package: [120 Units]
In Commercial Distribution

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 Date2021-12-23
Device Publish Date2021-12-15

On-Brand Devices [DANZ]

16970289035042Infrared Body Thermometer
16970289035059Non Contact Infrared Body Thermometer
06970289035182Non Contact Infrared Body Thermometer
16970289035196Infrared Body Thermometer
06970289035175Infrared Body Thermometer
16970289035264Infrared Body Thermometer
16970289035455Infrared Body Thermometer
16970289035530Non Contact Infrared Body Thermometer

Trademark Results [DANZ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DANZ
DANZ
98460531 not registered Live/Pending
DANZ NEW YORK CORP
2024-03-21
DANZ
DANZ
97736741 not registered Live/Pending
HETAIDA TECHNOLOGY CO., LTD.
2022-12-30
DANZ
DANZ
97603406 not registered Live/Pending
Li Jingbo
2022-09-22
DANZ
DANZ
97022483 not registered Live/Pending
Gla-Gla LLC
2021-09-10
DANZ
DANZ
88556623 not registered Live/Pending
Yang,Jie
2019-07-31
DANZ
DANZ
88552071 not registered Live/Pending
Yang,Jie
2019-07-31
DANZ
DANZ
88531407 not registered Live/Pending
Yang,Jie
2019-07-23
DANZ
DANZ
85647388 4506162 Live/Registered
Rogers, Daniel A.
2012-06-08
DANZ
DANZ
79407897 not registered Live/Pending
Guangdong Danzi Group Co., Ltd
2024-07-02
DANZ
DANZ
79293503 not registered Live/Pending
Guangdong Danzi Group Co., Ltd
2020-06-29
DANZ
DANZ
79136058 4586508 Live/Registered
Guangzhou City Baiyun Lianjia Fine Chemical Factory
2013-06-14
DANZ
DANZ
77349423 not registered Dead/Abandoned
BASCO IP L.P.
2007-12-11

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