FDA.reportPublic FDA data

JB CERVELLO 64

Primary DI
00850154007055
Brand
JB CERVELLO 64
Company
BLACKROCK NEUROMED, LLC
Model
7524
Catalog number
7524
Device description
JackBox with 64 Common Reference Inputs, with 6 of them to be switched to Bipolar, to be used with CERVELLO 64 Series Headboxes
Published
2016-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWKConditioner, Signal, Physiological
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWKConditioner, Signal, PhysiologicalNeurology2
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850154007055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850154007055008501540070558501540070550850154007055

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalography telemetric monitoring systemAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-994-5662support@blackrockneuromed.com

Regulatory Flags#

DUNS number
069799474
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850154007086CERVELLO SOFTWARERS-0003RS-00032016-12-06
00850154007079MORPHEUSNM-0354NM-03542016-12-07
00850154007000CERVELLO 32751175112016-07-15
00850154007017CERVELLO 64752375232016-12-05
00850154007024CERVELLO 32 WNM-0261NM-02612016-12-06
00850154007031CERVELLO 64 WNM-0262NM-02622016-12-06
00850154007048JB CERVELLO 32751275122016-12-06
00850154007062CERVELLO STIMNM-0353NM-03532016-12-06

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Primary DI, Brand, Company table
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00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
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18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
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18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
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08720256698296Onera STS 2Onera B.V.OLV2026-05-15
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