MRIaudio Over-Ear Headphones 330

GUDID B6693301

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.

MRIAUDIO, INC.

Headphones

• Primary Device ID: B6693301
• NIH Device Record Key: e5cb6348-e372-40be-979c-bb14aed13148
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRIaudio Over-Ear Headphones
• Version Model Number: 330
• Catalog Number: 330
• Company DUNS: 026681280
• Company Name: MRIAUDIO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com
• Phone: 8584270679
• Email: support@mriaudio.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6693301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180100

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-14
• Device Publish Date: 2018-10-05

On-Brand Devices [MRIaudio Over-Ear Headphones]

• B6693301: MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to li
• B6693300: MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to l