AccessGUDID - DEVICE: Patient Response Button (04260223140884)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Response Button
Version or Model: 100171
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PATH medical GmbH

Primary DI Number: 04260223140884
Issuing Agency: GS1
Commercial Distribution End Date: February 24, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

Device Description: Patient response button. PATH MEDICAL is not manufacturer or Labeler of this product. This Product was uploaded to GUDID erroneously by PATH MEDICAL.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWJ	Stimulator, Auditory, Evoked Response
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133012	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: 51e3193b-9791-4073-91d4-cc803ebfb2eb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016