| Primary Device ID | 00860334002121 |
| NIH Device Record Key | 51a2d7cf-0665-4903-97b2-748c96553198 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports |
| Version Model Number | 4.5.0.7 |
| Company DUNS | 191819023 |
| Company Name | VISTA PARTNERS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com | |
| Phone | 888-733-8804 |
| support@vistalifesciences.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860334002121 [Primary] |
| POM | Computerized Cognitive Assessment Aid For Concussion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
| 00860334002121 - ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports | 2023-08-14The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System 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 a 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 Test System 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 result 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 Test System 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. |
| 00860334002121 - ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports | 2023-08-14 The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer- |
| 00860334002114 - ANAM Test System | 2019-12-04 The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to |
| 00860334002107 - ANAM Test System: Military Battery | 2018-06-01 The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective |