RAPID GUARD Non-contact Infrared Thermometer

GUDID 06953775659475

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin
Primary Device ID06953775659475
NIH Device Record Key31f9de22-7ada-442f-af97-4c19f5dd9cfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAPID GUARD Non-contact Infrared Thermometer
Version Model NumberAET-R1B1-R
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
GS106953775659475 [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 Date2022-12-15
Device Publish Date2022-12-07

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