Genius 2

GUDID 00697077001933

Amico Diagnostic Incorporated

Infrared patient thermometer, ear Infrared patient thermometer, ear
Primary Device ID00697077001933
NIH Device Record Key71cb5abb-a462-4a50-a57e-f591d5b21b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius 2
Version Model NumberTT-D-IR
Company DUNS203163290
Company NameAmico Diagnostic Incorporated
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100697077001933 [Primary]

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-14

On-Brand Devices [Genius 2]

00697077001933TT-D-IR
00697077001926TT-A-IR
00697077002596TT-F-IR

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