MEDRACHEL Non-contact Infrared Thermometer

GUDID 06953775600170

Alicn Medical Shenzhen, Inc.

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Primary Device ID06953775600170
NIH Device Record Keyb59c727e-01fb-480a-992e-9e86fa8ac268
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRACHEL Non-contact Infrared Thermometer
Version Model NumberAET-R1D1-E
Company DUNS548040741
Company NameAlicn Medical Shenzhen, Inc.
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106953775600170 [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 Date2020-07-23
Device Publish Date2020-07-15

On-Brand Devices [MEDRACHEL Non-contact Infrared Thermometer]

06953775600170AET-R1D1-E
06953775600163AET-R1B1-M

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