AccessGUDID - DEVICE: MRIaudioPREM1000 with MRIview (B66935001)

GUDID

Device Identifier (DI) Information

Brand Name: MRIaudioPREM1000 with MRIview
Version or Model: 3500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3500
Company Name: MRIAUDIO, INC.

Primary DI Number: B66935001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026681280 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193102	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd13aa65-ee52-4d5f-9860-1aaa2cae67c9
Public Version Date: January 20, 2020
Public Version Number: 1
DI Record Publish Date: January 10, 2020