Etekcity Non-Contact Infrared Body Thermometer

GUDID 00817915020142

ETEKCITY CORPORATION

Infrared patient thermometer, skin
Primary Device ID00817915020142
NIH Device Record Keycc14c847-db73-43e5-83ca-496627bc297c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEtekcity Non-Contact Infrared Body Thermometer
Version Model NumberHTD8816C
Company DUNS079578783
Company NameETEKCITY 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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817915020142 [Primary]
GS110817915020149 [Package]
Package: Outer Carton [40 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 Date2020-07-20
Device Publish Date2020-07-10

Devices Manufactured by ETEKCITY CORPORATION

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10817915023218 - Etekcity Smart Fitness Scale2024-04-01
10817915029159 - Etekcity Blood Pressure Monitor2022-11-15
00817915028209 - Etekcity Smart Fitness Scale2021-09-01
10817915028213 - Etekcity Smart Fitness Scale2021-09-01

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