DEVICE: Lifelines iEEG Portable Laptop System Wireless (05694110063038)

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Device Identifier (DI) Information

Lifelines iEEG Portable Laptop System Wireless
KHW1030

Kvikna Medical ehf.
05694110063038
GS1
1
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electroencephalographic monitoring system, portable A mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.
Electroencephalograph A line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.
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FDA Product Code

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Product Code Product Code Name
OLT Non-Normalizing Quantitative Electroencephalograph Software
GWQ Full-Montage Standard Electroencephalograph
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 18, 2016
January 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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