MRIaudioPREM1000 with MRIview 3500

GUDID B66935001

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

MRIAUDIO, INC.

Patient audiovisual communication/entertainment system

• Primary Device ID: B66935001
• NIH Device Record Key: cd13aa65-ee52-4d5f-9860-1aaa2cae67c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRIaudioPREM1000 with MRIview
• Version Model Number: 3500
• Catalog Number: 3500
• 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	B66935001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193102

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

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: 2020-01-20The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
• 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: 2019-11-14 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