AccessGUDID - DEVICE: Component Neuromonitoring System (B485CNS3001)

GUDID

Device Identifier (DI) Information

Brand Name: Component Neuromonitoring System
Version or Model: CNS-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOBERG RESEARCH INC

Primary DI Number: B485CNS3001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029957656 *Terms of Use

Device Description: Domestic (U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

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):	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?
38736	Electroencephalographic monitoring system	An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph
ORT	Burst Suppression Detection Software For Electroencephalograph
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
OMA	Amplitude-Integrated Electroencephalograph
MUD	Oximeter, Tissue Saturation
OLT	Non-Normalizing Quantitative Electroencephalograph Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080217	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: adfa36b9-1928-4eda-9f43-8b1f8fb654b0
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: December 21, 2017