MRIaudioPREM1000 1000

GUDID B66910001

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

MRIAUDIO, INC.

Patient audiovisual communication/entertainment system Patient audiovisual communication/entertainment system

• Primary Device ID: B66910001
• NIH Device Record Key: b6c22435-f73b-43d1-9a6c-e35e9ca78e08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRIaudioPREM1000
• Version Model Number: 1000
• Catalog Number: 1000
• Company DUNS: 026681280
• Company Name: MRIAUDIO, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B66910001 [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

Devices Manufactured by MRIAUDIO, INC.

• B66916001 - MRIaudio1600: 2020-03-24 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66914001 - MRIaudio1400: 2020-02-07 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66930001 - MRIview: 2020-01-20 The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment.
• B66935001 - MRIaudioPREM1000 with MRIview: 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu
• B66935011 - MRIaudioPREM1001 with MRIview: 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu
• B66910001 - MRIaudioPREM1000: 2019-11-14The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
• B66910001 - MRIaudioPREM1000: 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66910011 - MRIaudioPREM1001: 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66910021 - MRIaudioPREM1002: 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h