FDA.reportPublic FDA data

Cognivue Advanced with Cart

Primary DI
00860000564007
Brand
Cognivue Advanced with Cart
Company
COGNIVUE, INC.
Model
Cart Unit
Published
2020-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKQComputerized Cognitive Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKQComputerized Cognitive Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130033000COGNIVUECerebral Assessment Systems, Inc.2015-06-05PKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000564007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000564007008600005640078600005640070860000564007

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive assessment softwareA software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
585-203-1969support@cognivue.com

Regulatory Flags#

DUNS number
115618437
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000564045Cognivue ClarityPortable Device Model 22025-06-12
00860000564052Cognivue ThrivePortable Device Model 22025-06-12
00860000564014Cognivue Advanced DesktopDesktop Unit2020-04-10
00860000564021Cognivue ClarityPortable Device2020-04-10
00860000564038Cognivue ThrivePortable Device2020-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852745007284BrainScope OneBrainscope Company, Inc.PKQ2024-06-04
00852745007253Baseline HeadsetBrainscope Company, Inc.PKQ2021-11-15
00852745007239BrainScope OneBrainscope Company, Inc.PKQ2021-02-16
00860000564014Cognivue Advanced DesktopCOGNIVUE, INC.PKQ2020-04-10
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.PKQ2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.PKQ2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.PKQ2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.PKQ2018-09-24
00852745007024Ahead 300Brainscope Company, Inc.PKQ2018-09-24
00852745007123BrainScope OneBrainscope Company, Inc.PKQ2018-09-24