AccessGUDID - DEVICE: MRIaudio Over-Ear Headphones (B6693301)

GUDID

Device Identifier (DI) Information

Brand Name: MRIaudio Over-Ear Headphones
Version or Model: 330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 330
Company Name: MRIAUDIO, INC.

Primary DI Number: B6693301
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026681280 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
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?
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.	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 [?]
K180100	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: e5cb6348-e372-40be-979c-bb14aed13148
Public Version Date: November 14, 2019
Public Version Number: 2
DI Record Publish Date: October 05, 2018