AccessGUDID - DEVICE: Galileo NT Line Software (08056446900642)

GUDID

Device Identifier (DI) Information

Brand Name: Galileo NT Line Software
Version or Model: B8640053000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EB NEURO SPA

Primary DI Number: 08056446900642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339182263 *Terms of Use

Device Description: Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.

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

FDA Product Code

[?]

Product Code	Product Code Name
JXE	Device, Nerve Conduction Velocity Measurement
OLV	Standard Polysomnograph With Electroencephalograph
GWJ	Stimulator, Auditory, Evoked Response
GWE	Stimulator, Photic, Evoked Response
GWF	Stimulator, Electrical, Evoked Response
IKN	Electromyograph, Diagnostic
GWQ	Full-Montage Standard Electroencephalograph
OLT	Non-Normalizing Quantitative Electroencephalograph Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142064	000
K242305	000
K242832	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: bdd6ca75-8c5a-445f-adda-22b303974d93
Public Version Date: May 23, 2025
Public Version Number: 2
DI Record Publish Date: May 25, 2020