CERVELLO 64

Basic Information

• Brand Name: CERVELLO 64
• Primary DI: 00850154007017
• Version / Model: 7523
• Catalog Number: 7523
• Company Name: BLACKROCK NEUROMED, LLC
• Labeler DUNS: 069799474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ecd47e1b-ec9c-41a7-9dda-8564098b1a75

Device Description

Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model

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: Yes
• 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
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2
GWK	Conditioner, Signal, Physiological	Neurology	882.1845	2
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	882.1400	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850154007017	GS1

Customer Contacts

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