FDA.reportPublic FDA data

CERVELLO 32

Primary DI
00850154007000
Brand
CERVELLO 32
Company
BLACKROCK NEUROMED, LLC
Model
7511
Catalog number
7511
Device description
Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model
Published
2016-07-15
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
00850154007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850154007000008501540070008501540070000850154007000

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
00850154007017CERVELLO 64752375232016-12-05
00850154007024CERVELLO 32 WNM-0261NM-02612016-12-06
00850154007031CERVELLO 64 WNM-0262NM-02622016-12-06
00850154007048JB CERVELLO 32751275122016-12-06
00850154007055JB CERVELLO 64752475242016-12-06
00850154007062CERVELLO STIMNM-0353NM-03532016-12-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
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00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
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00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
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18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
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