MRIaudio Over-Ear Headphones

Basic Information

• Brand Name: MRIaudio Over-Ear Headphones
• Primary DI: B6693300
• Version / Model: 330
• Catalog Number: 330
• Company Name: MRIAUDIO, INC.
• Labeler DUNS: 026681280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-06
• Public Version: 1
• Public Version Date: 2026-03-16
• Public Version Status: New
• Public Device Record Key: 15d94beb-d0c2-4054-b722-856801870dd7

Device Description

MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection.

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 Safe
• 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
30075	Headphones	A device that is worn on the head, typically fitting over both ears, but that may fit over one ear. It supplies the user with audio input increasing the sound volume of, e.g., television, radio, or a communication amplifier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6693300	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K180100	000