Cognition Chronicle

Basic Information

• Brand Name: Cognition Chronicle
• Primary DI: 00860007318733
• Version / Model: CHR-COG-10
• Company Name: Qr8 Health Inc
• Labeler DUNS: 080506730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-11
• Public Version: 1
• Public Version Date: 2022-02-21
• Public Version Status: New
• Public Device Record Key: cefdf5a3-ae53-4282-acbc-54ea92566173

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: Yes
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007318733	GS1