MobiTrak Software v3.00

GUDID B292M9170810

MEDTRAK VNG, INC.

Eye movement analysis system

• Primary Device ID: B292M9170810
• NIH Device Record Key: d9c7b6a7-f9c2-415e-b91c-7eac1145fdf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MobiTrak Software v3.00
• Version Model Number: M917081
• Company DUNS: 968641824
• Company Name: MEDTRAK VNG, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B292M9170810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925111

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by MEDTRAK VNG, INC.

• B2924040100 - MedTrakVNG MobiTrak System: 2018-07-06
• B2924091070 - MedTrakVNG Footswitch: 2018-07-06
• B292M9170810 - MobiTrak Software v3.00: 2018-07-06
• B292M9170810 - MobiTrak Software v3.00: 2018-07-06
• B292M9174150 - MobiTrakVNG Receiver: 2018-07-06
• B292M9203020 - MedTrakVNG Interface Controller: 2018-07-06
• B292M9205200 - MedTrakVNG Goggle: 2018-07-06