FDA.reportPublic FDA data

Cerebralogik aEEG

Primary DI
07290102932399
Brand
Cerebralogik aEEG
Company
M.T.R.E. ADVANCED TECHNOLOGIES LTD.
Model
VL6X00_Kit
Catalog number
781OPT138
Device description
Electroencephalograph kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290102932399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290102932399072901029323997290102932399

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electroencephalographicA small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+2152591020info@mmi.co.il

Regulatory Flags#

DUNS number
532022530
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107580526CritiCool Pro VL4000N 115VAC100-000132016-09-24
07290107580540CritiCool Pro VL4000M 115VAC100-001132016-09-24
07290107580564CritiCool Pro VL4500N 115VAC100-002132016-09-24
07290107580588CritiCool Pro VL4500M 115VAC100-003132016-09-26
07290102932313CritiCool ProVitaLogik4000 3/5Lead,NI Nellcor Blue681-0R0-0132016-09-24
07290102932337CritiCool ProVitaLogik4000 3/5Lead,NI Masimo Blue681-0R0-0232016-09-24
07290102932344CritiCool ProVitaLogik4500 3/5Lead Nellcor Blue681-0R0-1132016-09-24
07290012127335CureWrap™Pediatric, 79-91cm (single)500-035312016-09-24
07290102932351CritiCool ProVitaLogik4500 3/5Lead Masimo Blue681-0R0-1232016-09-24
07290102932368CerebralogikModule CC Set Color681-138-0002016-09-24
07290102932375Cerebralogik Module VL Set Color681-138-0102016-09-24
07290102932382Cerebralogik aEEG VL4X00_Kit 681-OPT-1382016-09-24
77290107580242CureWrap™X-Large Pediatric 122-135 cm (single)PED-X10012016-09-24
77290107580266CureWrap™X-Large Pediatric over 135cm (single)PED-X20012016-09-24

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Primary DI, Brand, Company table
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10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
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09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
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08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
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10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
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