TekCare Touch Free Infrared Thermometer

GUDID 04710953421307

The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can b

AVITA CORPORATION

Infrared patient thermometer, ear
Primary Device ID04710953421307
NIH Device Record Key44b5fe1e-98d9-4b8a-8b2c-021a1851b681
Commercial Distribution StatusIn Commercial Distribution
Brand NameTekCare Touch Free Infrared Thermometer
Version Model NumberNT11
Company DUNS658023275
Company NameAVITA CORPORATION
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104710953421291 [Primary]
GS104710953421307 [Package]
Contains: 04710953421291
Package: [40 Units]
In Commercial Distribution

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 Date2019-01-31
Device Publish Date2018-12-31

On-Brand Devices [TekCare Touch Free Infrared Thermometer]

04710953421307The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human b
04710953421529The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human b

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