Cognivue Advanced with Cart

GUDID 00860000564007

COGNIVUE, INC.

Cognitive assessment software
Primary Device ID00860000564007
NIH Device Record Key0ccc34bc-d52f-4d43-9e29-840f46a3b5c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCognivue Advanced with Cart
Version Model NumberCart Unit
Company DUNS115618437
Company NameCOGNIVUE, 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 Batchfalse
Serial Numbertrue
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
GS100860000564007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKQComputerized Cognitive Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

Devices Manufactured by COGNIVUE, INC.

00860000564007 - Cognivue Advanced with Cart2020-04-20
00860000564007 - Cognivue Advanced with Cart2020-04-20
00860000564014 - Cognivue Advanced Desktop2020-04-20
00860000564021 - Cognivue Clarity2020-04-20
00860000564038 - Cognivue Thrive2020-04-20

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