AccessGUDID - DEVICE: CNS Envision (B485VIS100)

GUDID

Device Identifier (DI) Information

Brand Name: CNS Envision
Version or Model: VIS-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOBERG RESEARCH INC

Primary DI Number: B485VIS100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029957656 *Terms of Use

Device Description: Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.

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?
47541	Bioelectrical signal analysis software	A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLT	Non-Normalizing Quantitative Electroencephalograph Software
OMA	Amplitude-Integrated Electroencephalograph
ORT	Burst Suppression Detection Software For Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192572	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: 709801aa-d45e-43ff-ba15-8f3da4b6ca4f
Public Version Date: January 07, 2022
Public Version Number: 2
DI Record Publish Date: October 28, 2020