Cognigram

Basic Information

• Brand Name: Cognigram
• Primary DI: 00860011464532
• Version / Model: 8.0.0
• Company Name: Cogstate Inc.
• Labeler DUNS: 787046742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-18
• Public Version: 1
• Public Version Date: 2025-01-27
• Public Version Status: New
• Public Device Record Key: ced22555-a325-46aa-b650-7b49a7d014ef

Device Description

Cognigram is a self-administered digital medical device powered by Cogstate Brief Battery. It measures cognitive functions, processes data, and auto-generates comprehensive test reports.

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	Medical Specialty	Regulation #	Device Class
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	882.1470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30895	Cause-and-effect assistive training device	A device designed to be used to assist a person with a disability with developing an understanding of cause and effect (i.e., what is the reason for something to happen and what will be the outcome should it happen).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011464532	GS1
Previous	00860011464518	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]