Model: DMR-0004
DI: 00810051680010
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3bea39e3-34d9-415e-8594-51ad03832456
Distribution Status:
In Commercial Distribution
DUNS Number:
078866200
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810051680010
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65064
Name: Eye-tracking neurological/brain injury assessment device
Definition:
An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.
FDA Product Codes
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Premarket Submissions
Submission Number:
K242116
Supplement Number:
000