Shielded Interface Unit

Basic Information

• Brand Name: Shielded Interface Unit
• Primary DI: 07090042055024
• Version / Model: SIU 2.0
• Company Name: Nordicneurolab AS
• Labeler DUNS: 671280238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-07
• Public Version: 7
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 9fb54d7e-2ef9-409c-9fbd-f616f7f4848f

Device Description

Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07090042055024	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092253	000