CALi-MEDi, CALIBEUR, iMeasure, iCalibeur

GUDID 06970000910132

Shenzhen Calibeur Industries Co., Ltd.

Infrared patient thermometer, skin
Primary Device ID06970000910132
NIH Device Record Key4b5c8283-63fa-4892-9cc3-46dfcbdcf75c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALi-MEDi, CALIBEUR, iMeasure, iCalibeur
Version Model NumberDT-8836P
Company DUNS546723214
Company NameShenzhen Calibeur Industries 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
GS106970000910132 [Primary]

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 Date2020-05-06
Device Publish Date2020-04-28

On-Brand Devices [CALi-MEDi, CALIBEUR, iMeasure, iCalibeur]

06970000910170DT-8836T
06970000910132DT-8836P

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