DCTclock

Basic Information

• Brand Name: DCTclock
• Primary DI: B626100930
• Version / Model: 10093
• Catalog Number: 10093
• Company Name: Linus Health, Inc.
• Labeler DUNS: 117137874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-16
• Public Version: 3
• Public Version Date: 2020-08-06
• Public Version Status: Update
• Public Device Record Key: 3b33c05e-fbae-410e-99ae-872b537451d7

Device Description

DCTclock Practice Test Form - clinical

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
30894	Drawing-test cognitive function analysis device	A device designed for professional assessment of a patient’s cognitive function by means of software-based analysis and interpretation of a drawing test (e.g., clock drawing test) performed by the patient. It consists of an electronic digital input device (e.g., pen with a built-in camera), and software; the results are typically combined with patient demographics to provide a summary report.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B626100931	HIBCC	shrink wrap	10	In Commercial Distribution
Primary	B626100930	HIBCC

Customer Contacts

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