Motorola

GUDID 16947468500097

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear
Primary Device ID16947468500097
NIH Device Record Key952f6479-f775-416e-88ea-6d12c75b10da
Commercial Distribution StatusIn Commercial Distribution
Brand NameMotorola
Version Model NumberTE-94
Company DUNS529903321
Company NameShenzhen Belter Health Measurement and Analysis 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
GS106947468500090 [Primary]
GS106947468500090 [Primary]
GS106947468500090 [Primary]
GS106947468500090 [Primary]
GS116947468500097 [Package]
Contains: 06947468500090
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS116947468500097 [Package]
Contains: 06947468500090
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS116947468500097 [Package]
Contains: 06947468500090
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS116947468500097 [Package]
Contains: 06947468500090
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS126947468500094 [Package]
Package: 20pcs/box [20 Units]
In Commercial Distribution
GS126947468500094 [Package]
Package: 20pcs/box [20 Units]
In Commercial Distribution
GS126947468500094 [Package]
Package: 20pcs/box [20 Units]
In Commercial Distribution
GS126947468500094 [Package]
Package: 20pcs/box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
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 Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

16947468500097 - Motorola2020-11-10
16947468500097 - Motorola2020-11-10
16947468500042 - belter2020-06-12
16947468500011 - belter2020-05-11
16947468554809 - Equate2020-05-04
16947468554779 - Bytech2020-03-27
16947468554786 - Bytech2020-03-27
16947468554793 - Eufy2020-03-27
26947468554745 - Eufy2020-03-26

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