AccessGUDID - DEVICE: Brain Gauge MD (00860000709408)

GUDID

Device Identifier (DI) Information

Brand Name: Brain Gauge MD
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CORTICAL METRICS, LLC

Primary DI Number: 00860000709408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809217487 *Terms of Use

Device Description: The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.

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?
63185	Cognitive assessment software	A 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.	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
Storage Environment Temperature: between 5 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 73 Millimeter
Width: 113 Millimeter
Height: 40 Millimeter

Device Record Status

Public Device Record Key: 57e6cf00-1be5-407a-9d38-41299cd64a49
Public Version Date: April 23, 2019
Public Version Number: 2
DI Record Publish Date: November 27, 2018