Home GUDID 00840682104272 NA
Primary DI 00840682104272
Brand NA
Company GE Healthcare Finland Oy
Model E-ENTROPY-01
Published 2016-05-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name OLW Index-generating electroencephalograph software OMC Reduced- montage standard electroencephalograph ORT Burst suppression detection software for electroencephalograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLW Index-Generating Electroencephalograph Software Neurology 2 OMC Reduced- Montage Standard Electroencephalograph Neurology 2 ORT Burst Suppression Detection Software For Electroencephalograph Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840682104272 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840682104272 00840682104272 840682104272 0840682104272
GMDN Terms# Term, Definition table Term Definition Patient monitoring system module, electroencephalographic A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 401966697 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00195278699923 PORTRAIT MMP01 MMP01 5514246-30 2023-10-26 00195278110435 PORTRAIT MMP01 MMP01 5514246 2023-09-01 00840682103152 TruSignal SpO2 TS-F2-GE 2016-06-16 00840682147811 CARESCAPE Software 3.2 NA 2026-04-15 00195278093998 PORTRAIT HUB01 HUB01 2096437-001 2023-09-01 00198953049181 NA PiCCO Continuous Cardiac Output Cable 2026-01-05 00198953066560 NA PiCCO Injectate Sensor Cable 2026-01-05 00198953030981 PORTRAIT HSWXB V1.2 5700672-12 2025-12-10 00840682136402 NA Cardiac Output Cable, 2.4 m/8 ft. 2104180-002 2018-08-10 00840682102872 NA D-lite Spirometry Kit 2m 7ft, 8004381 2016-08-15 00840682103169 TruSignal SpO2 TS-F4-MC 2016-07-15 00840682103190 TruSignal SpO2 TS-F4-N 2016-06-16 00840682103343 TruSignal SpO2 TS-F1-H 2016-06-16 00840682103367 TruSignal SpO2 TS-E4-H 2016-06-16 00840682103381 TruSignal SpO2 TS-E4-N 2016-06-16 00840682103442 NA Pre-conf. EEG Lead Set 2 General, 898051 2016-06-16 00840682136358 NA Invasive Blood Pressure Cable, Argon, Single, 1.2 2104166-002 2018-08-10 00840682136365 NA Invasive Blood Pressure Cable, Utah/Biotrans, Sing 2104107-002 2018-08-13 00840682136464 NA Invasive Blood Pressure Cable, Utah/Biotrans, Dual 2104107-004 2018-08-10 00840682136501 NA Invasive Blood Pressure Cable, ICU Medical Transpa 2104158-004 2018-08-10
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