MobiTrak Software v3.00

Basic Information

• Brand Name: MobiTrak Software v3.00
• Primary DI: B292M9170810
• Version / Model: M917081
• Company Name: MEDTRAK VNG, INC.
• Labeler DUNS: 968641824
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d9c7b6a7-f9c2-415e-b91c-7eac1145fdf1

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
GWN	Nystagmograph	Neurology	882.1460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12609	Eye movement analysis system	An assembly of mains electricity (AC-powered) devices designed to measure, evaluate and record the movement of the eyes. The device is intended to measure ocular dynamics, typically measuring both horizontal and vertical eye movements. This device can include a stimulus source (e.g., a light bar), a sensing device (e.g., video or infrared cameras), a computer, and a recorder. Some systems may include cameras and/or eyelid trackers mounted on spectacles or headbands.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B292M9170810	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K925111	000