AccessGUDID - DEVICE: ANAM Test System: Military Battery (00860334002107)

GUDID

Device Identifier (DI) Information

Brand Name: ANAM Test System: Military Battery
Version or Model: 4.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VISTA PARTNERS, LLC

Primary DI Number: 00860334002107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191819023 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58290	Psychological assessment software	A screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTY	Computerized Cognitive Assessment Aid, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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