AccessGUDID - DEVICE: Headphones (07090042053013)

GUDID

Device Identifier (DI) Information

Brand Name: Headphones
Version or Model: HP 1.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nordicneurolab AS

Primary DI Number: 07090042053013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 671280238 *Terms of Use

Device Description: Head Phones is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.

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):	No
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?
35368	Auditory stimulator	A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.	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 [?]
K092253	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: 1b97e242-4a9b-4914-a3f8-8e9996e480ce
Public Version Date: June 02, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2016