I-Portal Super VNG SVNG

GUDID B290SVNG1

Video-Nystagmograph

N K I

Caloric vestibular-stimulation system Caloric vestibular-stimulation system

• Primary Device ID: B290SVNG1
• NIH Device Record Key: cf072a12-dc07-4c4a-a0e2-7efa05e1dbe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-Portal Super VNG
• Version Model Number: SVNG
• Catalog Number: SVNG
• Company DUNS: 151391174
• Company Name: N K I
• 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: false
• Serial Number: true
• 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	B290SVNG1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143607

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: 2017-01-02

On-Brand Devices [I-Portal Super VNG]

• B290SVNG1: Video-Nystagmograph
• B290SVNG0: Video-Nystagmograph