AccessGUDID - DEVICE: CNS Vital Signs Web (00860013886103)

GUDID

Device Identifier (DI) Information

Brand Name: CNS Vital Signs Web
Version or Model: 2.0.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CNS Vital Signs, LLC

Primary DI Number: 00860013886103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153552802 *Terms of Use

Device Description: CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.

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:	Yes
Prescription Use (Rx):	No
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: 4f29bcad-4030-49f6-93ed-e3bdc99106cc
Public Version Date: July 15, 2025
Public Version Number: 1
DI Record Publish Date: July 07, 2025