ANAM Test System: Military Battery - The ANAM Test System: Military Battery (ANAM - VISTA PARTNERS, LLC

Duns Number:191819023

Device Description: The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device t The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.

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More Product Details

Catalog Number

-

Brand Name

ANAM Test System: Military Battery

Version/Model Number

4.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PTY

Product Code Name

Computerized Cognitive Assessment Aid, Exempt

Device Record Status

Public Device Record Key

3b0d8c3f-1824-4e81-acbe-714fe7149bf3

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

May 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISTA PARTNERS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2