AccessGUDID - DEVICE: Wireless Headphones (00856181003374)

GUDID

Device Identifier (DI) Information

Brand Name: Wireless Headphones
Version or Model: 37
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEOCOIL, LLC

Primary DI Number: 00856181003374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 781155176 *Terms of Use

Device Description: The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.

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?
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 [?]
K133670	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: 560dba0a-4d3c-4112-85dd-6c4f7a017405
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 16, 2017