Visual System Power Supply

GUDID 07090042052092

Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays.

Nordicneurolab AS

Visual stimulator

• Primary Device ID: 07090042052092
• NIH Device Record Key: 7f5c0151-0f8f-47a0-b472-4c802d307ddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visual System Power Supply
• Version Model Number: VPS-1.1
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	07090042052092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191032

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-03-01

On-Brand Devices [Visual System Power Supply ]

• 07090042052092: Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure contai
• 07090042052122: Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure contai