DR.TALBOT'S Non-contact Infrared Thermometer

GUDID 06953775658263

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin
Primary Device ID06953775658263
NIH Device Record Key96262367-e261-4c1e-8f44-d115b3af71cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR.TALBOT'S Non-contact Infrared Thermometer
Version Model NumberAET-R1F1-D
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
GS106953775658263 [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 Date2020-05-22
Device Publish Date2020-05-14