Infrared thermometer

GUDID 26947468535751

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

Infrared patient thermometer, ear
Primary Device ID26947468535751
NIH Device Record Key77bef029-2403-47ec-b836-c4e421c5791b
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfrared thermometer
Version Model NumberTE-68
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
GS106947468535757 [Primary]
GS116947468535754 [Package]
Contains: 06947468535757
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS126947468535751 [Package]
Contains: 16947468535754
Package: 40pcs/box [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 Date2018-08-28
Device Publish Date2018-07-28

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

16947468500363 - RITE AID2023-09-28
16947468500356 - Bytech2023-07-04
16947468500349 - RITE AID2023-06-05
16947468500332 - NO2023-05-31
16947468500325 - Bluedot2023-04-06
16947468500318 - CARE TOUCH2022-11-22
16947468500295 - biotricity2022-08-26
16947468500301 - biotricity2022-08-26

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