Comfort Zone CLEAN

GUDID 10810021178285

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin
Primary Device ID10810021178285
NIH Device Record Key6d5bc8de-a05a-4bda-a5c1-1277a4fe299a
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort Zone CLEAN
Version Model NumberHW-F7
Company DUNS544332470
Company NameDongguan SIMZO Electronic 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021178288 [Primary]
GS110810021178285 [Package]
Contains: 00810021178288
Package: [1 Units]
In Commercial Distribution
GS120810021178299 [Package]
Package: [8 Units]
In Commercial Distribution
GS130810021178036 [Package]
Contains: 20810021178299
Package: [2 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 Date2020-09-02
Device Publish Date2020-08-25

Devices Manufactured by Dongguan SIMZO Electronic Technology Co., Ltd.

00810021174013 - NA2024-01-11
10810021174034 - NA2024-01-11
00810021171166 - SIMZO2021-07-28
00810021171173 - SIMZO2021-07-28
00810021171180 - SIMZO2021-07-28
00810021171197 - simzo2021-07-28
00810021171203 - SIMZO2021-07-28
00810021171210 - SIMZO2021-07-28

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