AccessGUDID - DEVICE: Cerebralogik (07290102932375)

GUDID

Device Identifier (DI) Information

Brand Name: Cerebralogik
Version or Model: Module VL Set Color
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 681-138-010
Company Name: M.T.R.E. ADVANCED TECHNOLOGIES LTD.

Primary DI Number: 07290102932375
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532022530 *Terms of Use

Device Description: Electroencephalograph kit

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Patient monitoring system module, electroencephalographic	A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

GMDN Preferred Term Name

GMDN Definition

Patient monitoring system module, electroencephalographic

A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 1039117b-54fa-4504-939f-ab72283337ee
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016