AccessGUDID - DEVICE: Live View Panel Version 1.3 (00817111020786)

GUDID

Device Identifier (DI) Information

Brand Name: Live View Panel Version 1.3
Version or Model: 1.3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Neurotronics, LLC

Primary DI Number: 00817111020786
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 036405363 *Terms of Use

Device Description: Live View Panel Version 1.3

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?
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
64938	Sleep disorder interpretive software, professional-only	An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
OLV	Standard Polysomnograph With Electroencephalograph
OLT	Non-Normalizing Quantitative Electroencephalograph Software
GWQ	Full-Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131415	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: ca2333e4-44cb-4dd4-af3d-39862c6bce9a
Public Version Date: April 10, 2025
Public Version Number: 9
DI Record Publish Date: September 22, 2016