FDA.reportPublic FDA data

TekCare Non-Contact Infrared Thermometer

Primary DI
04710953421598
Brand
TekCare Non-Contact Infrared Thermometer
Company
AVITA CORPORATION
Model
NT19
Device description
The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
Published
2020-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710953421604PackageGS140In Commercial Distribution
04710953421598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710953421604047109534216044710953421604
04710953421598047109534215984710953421598

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
658023275
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710953421628Harbor Freight Tools584602020-10-13
04710953421635Harbor Freight Tools584602020-10-13
04710953421604TekCare Non-Contact Infrared ThermometerNT192020-05-15
04710953421512TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421529TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421468TekCare Green-Type Infrared ThermometerNT1G2019-11-29
04710953421338TekCare Blood Pressure MonitorBPM192018-12-31
04710953420942Blood pressure monitor622202017-04-24
04710953421161Blood pressure monitorBPA-O3002018-08-12
04710953421345TekCare Blood Pressure MonitorBPM192018-12-31
04710953421291TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421314TekCare Infrared ThermometerTS462018-12-31
04710953421307TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421321TekCare Infrared ThermometerTS462018-12-31

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Primary DI, Brand, Company table
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22