FDA.reportPublic FDA data

DANA™

Primary DI
00860011042105
Brand
DANA™
Company
Anthrotronix, Inc.
Model
1.0
Published
2023-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LQDRecorder, Attention Task Performance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQDRecorder, Attention Task PerformanceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141865000DANAAnthrotronix, Inc.2014-10-15LQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011042105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011042105008600110421058600110421050860011042105

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

Regulatory Flags#

DUNS number
128374548
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011067610DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067627DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067634DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067641DynavisionDynavision Global Holdings, LLCLQD2024-06-10
07350103930012QbCheckQbtech ABLQD2023-06-14
07350103930067QbTestQbtech ABLQD2023-06-14
00862290000302T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000319T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000326T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000333T.O.V.A.TOVA COMPANY, THELQD2020-01-02