TekCare Green-Type Infrared Thermometer

GUDID 04710953421468

The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.

AVITA CORPORATION

Infrared patient thermometer, ear
Primary Device ID04710953421468
NIH Device Record Key129b40d3-5169-4263-8d80-d936da415dde
Commercial Distribution StatusIn Commercial Distribution
Brand NameTekCare Green-Type Infrared Thermometer
Version Model NumberNT1G
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

Customer Support Contacts

Phone+886 285121568
Emailamber_dong@avita.com.tw

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104710953421468 [Primary]
GS104710953421475 [Package]
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 Date2019-12-09
Device Publish Date2019-11-29

Devices Manufactured by AVITA CORPORATION

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04710953420942 - Blood pressure monitor2019-11-08 The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and
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04710953421345 - TekCare Blood Pressure Monitor2019-11-08 BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and he
04710953421307 - TekCare Touch Free Infrared Thermometer2019-01-31 The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic

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