MRIaudioPREM1004

Basic Information

• Brand Name: MRIaudioPREM1004
• Primary DI: B66910051
• Version / Model: 1005
• Catalog Number: 1005
• Company Name: MRIAUDIO, INC.
• Labeler DUNS: 026681280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: 266f1a39-c818-4dc4-8e51-4351d9ccba87

Device Description

The MRIaudio PREM1005 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.

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: 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
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64404	Patient audiovisual communication/entertainment system	An assembly of devices intended to be used to provide a communication and/or entertainment channel for a patient undergoing a radiological examination (e.g., MRI scan). It typically consists of a control unit, intercom, and data communication hub; with earplugs, or other personal audio device, and/or a visual monitor for the patient. It may be supplied in a modular fashion.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B66910051	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K180100	000