CERVELLO SOFTWARE

Basic Information

• Brand Name: CERVELLO SOFTWARE
• Primary DI: 00850154007086
• Version / Model: RS-0003
• Catalog Number: RS-0003
• Company Name: BLACKROCK NEUROMED, LLC
• Labeler DUNS: 069799474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-06
• Public Version: 3
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 4af18e92-78b9-4648-8e44-6de9668eadb0

Device Description

Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	882.1400	2
GWK	Conditioner, Signal, Physiological	Neurology	882.1845	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35626	Electroencephalography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electroencephalographic (EEG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	No	Obsolete
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850154007086	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]