FDA UDI In Commercial Distribution 🇺🇸 United States

CNS Vital Signs VSC

DI: 00860013886127 · Model: 1.0 · CNS Vital Signs, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CNS Vital Signs VSC
Primary DI
00860013886127
Version / Model
1.0
Company Name
CNS Vital Signs, LLC
Labeler DUNS
153552802
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-01
Public Version
1
Public Version Date
2025-09-09
Public Version Status
New
Public Device Record Key
df8df95d-9c1c-443d-ad5c-4f220825b923

Device Description

CNS Vital Signs cognitive testing installed locally on iOS platform. A set of Cognitive tests and clinical questionaires that can be administered in the office. Requires an internet connection.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PTY Computerized Cognitive Assessment Aid, Exempt

GMDN Terms

Code Name
58290 Psychological assessment software

Identifiers

Type ID
Primary 00860013886127