Verilux

Basic Information

• Brand Name: Verilux
• Primary DI: 00768533140067
• Version / Model: VT43WW3
• Company Name: BEAR DOWN CONSULTING
• Labeler DUNS: 040869867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 2
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: ae3058a2-0628-4d1d-ac7a-5de16ab6c59b

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: 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
KZF	Device, Medical Examination, Ac Powered	General Hospital	880.6320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63387	Neurological visible-light phototherapy unit, home-use	An electrically-powered device typically in the form of a computer monitor or ceiling-mounted panel designed to emit specific wavelengths of visible light to help treat the symptoms of a neurological disorder (e.g., delirium, Parkinson’s disease) in the home and healthcare facility. It is intended to help improve the patient's mental condition, sleep, mood, motor function, and/or reduce other disease-related symptoms; it is not dedicated to the treatment of seasonal affective disorder (SAD). The patient is intended to sit in front of or lie below the device for prescribed periods each day.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00768533140067	GS1