| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B143700001112 | SleepView Starter Kit | 700-0011-1 | Portable Sleep Monitor kit for Home Sleep Testing | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView |
| 2 | B14350202060 | SleepView | 502-0206 | SleepView RIP Belt Interface | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView RIP Belt Interface |
| 3 | B143502020450 | Extra Extra Large - Single | 502-0204-5 | Single use, extra extra large respiratory belt. | GWQ | Full-Montage Standard Electroencephalograph | ReadyRip Belt | |
| 4 | B143502020440 | Extra Large - Single | 502-0204-4 | Single use, extra large respiratory belt. | GWQ | Full-Montage Standard Electroencephalograph | ReadyRip Belt | |
| 5 | B143502020430 | Large - Single | 502-0204-3 | Single use, large respiratory belt. | GWQ | Full-Montage Standard Electroencephalograph | ReadyRip Belt | |
| 6 | B143502020420 | Medium - Single | 502-0204-2 | Single use, medium respiratory belt. | GWQ | Full-Montage Standard Electroencephalograph | ReadyRip Belt | |
| 7 | B143700001192 | ProAct SleepView Starter Kit | 700-0011-9 | Custom SleepView Starter Kit configuration for ProAct | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView Starter Kit |
| 8 | B143700001172 | Consignment | 700-0011-7 | SleepView Consignment Kit to be used for evaluation. | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView Starter Kit |
| 9 | B1437000011112 | International | 700-0011-11 | SleepView International Starter Kit | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView Starter Kit |
| 10 | B1437000011102 | Premium Rental Starter Kit | 700-0011-10 | SleepView Rental Starter Kit including 15 premium study kits | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView Starter Kit |
| 11 | B14360201292 | International Sensor Kit | 602-0129 | Optional accessory kit for use with SleepScout - International customers | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 12 | B14360200511 | Optional Sensor Kit | 602-0051 | Optional accessory kit for use with SleepScout | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 13 | B14350201490 | Computer Unit | 502-0149 | SleepScout Computer Unit for recording/viewing SleepScout acquisition data in re SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC. | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 14 | B143502014610 | SleepScout Mobile Unit | 502-0146-1 | Wireless portable sleep monitor for sleep testing | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 15 | B14350101320 | Computer Unit | 502-0132 | Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real t Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC. | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 16 | B14350100280 | XPOD Interface | 501-0028 | SPO2 Interface cable for use with SleepScout PSG system | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout |
| 17 | B14360201261 | Two Belt - XXLarge | 602-0123 | Single use, premium study kit with two XXlarge ReadyRip Belts | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 18 | B14360201231 | Two Belt - XLarge | 602-0123 | Single use, premium study kit with two Xlarge ReadyRip Belts | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 19 | B14360201201 | Two Belt - Large | 602-0120 | Single use, premium study kit with two large ReadyRip Belts | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 20 | B14360201141 | Extra Extra Large - Single | 602-0114 | Single use, premium study kit extra extra large. | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 21 | B14360201111 | Extra Large - Single | 602-0111 | Single use, premium study kit extra large. | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 22 | B14360201081 | Large - Single | 602-0108 | Single use, premium study kit large. | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 23 | B14360200791 | Proact - Single | 602-0079 | Single use, proact premium study kit. | GWQ | Full-Montage Standard Electroencephalograph | Premium Study Kit | |
| 24 | B14360200451 | Sensor Kit | 602-0045 | Standard accessory kit included with Sapphire Starter Kit | GWQ | Full-Montage Standard Electroencephalograph | 2 | Sapphire |
| 25 | B14350201700 | LifeSense to Sapphire Serial Cable | 502-0170 | LifeSense Serial Interface cable for use with Sapphire PSG system | GWQ | Full-Montage Standard Electroencephalograph | 2 | Sapphire |
| 26 | B14350201440 | XPOD Interface | 502-0144 | SPO2 Interface cable for use with Sapphire PSG system | GWQ | Full-Montage Standard Electroencephalograph | 2 | Sapphire |
| 27 | B143502012540 | Sapphire 2400 Patient Unit | 502-0125-4 | Wireless PSG Patient Unit for Sleep Testing | GWQ | Full-Montage Standard Electroencephalograph | 2 | Sapphire |
| 28 | B143700000712 | Standard | 700-0007-1 | SleepScout Starter Kit | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepScout Starter Kit |
| 29 | B143700000922 | Standard | 700-0009-2 | Sapphire PSG 2400 Starter Kit. | GWQ | Full-Montage Standard Electroencephalograph | 2 | Sapphire PSG 2400 Starter Kit |
| 30 | B14360201171 | International - Single | 602-0117 | Single use international study kit. | GWQ | Full-Montage Standard Electroencephalograph | Study Kit | |
| 31 | B14360200761 | Compatible with Thermistor - Single | 602-0076 | Single use study kit (compatible with thermistor). | GWQ | Full-Montage Standard Electroencephalograph | Study Kit | |
| 32 | B14360200751 | Single | 602-0075 | GWQ | Full-Montage Standard Electroencephalograph | Study Kit | ||
| 33 | B143502016910 | SleepView II | 502-0169-1 | Portable Sleep Monitor for Home Sleep Testing | GWQ | Full-Montage Standard Electroencephalograph | 2 | SleepView |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08800108500363 | ISW-MUS101 | iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measuremen iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurementtechnology to an international 10-20 system compliant size-adjustable headset.iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLEwireless connection to the iSyncWaveTM App. The data is displayed and recorded via theiSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require apreparation process(e.g., applying conductive gel), to obtain high quality EEG signals.Before measuring the EEG, you can check the impedance of each electrode under theimpedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digitalconverter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz andthen converted to digital data at 24-bit resolution.This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and1 ground electrode. The measured data can be digitally converted to common average,longitudinal and transverse montage. The measured data is automatically uploaded toa secure cloud server via Wi-Fi connection and saved securely. The data saved in thecloud server can be seen on the iSyncWaveTM app.iSyncWaveTM can be only used by professional and/or medical personnel with producttraining and experience in EEG measurement. The professional and/or medicalpersonnel can check the signal quality in real time and refer to the measured data inclinical practice. | iSyncWave | IMEDISYNC, INC. | |
| 2 | 08437017440796 | WF | Enobio is a Wireless EEG, performs electroencephalographic measures with non-inv Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology.Enobio is a Wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording. | ENOBIO | NEUROELECTRICS BARCELONA SL | |
| 3 | 08056446900956 | B8830073320 | Patient-interface for EEG ambulatory recorder | BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL | EB NEURO SPA | |
| 4 | 08056446900949 | B8830073310 | Patient-interface for EEG ambulatory recorder | BE Micro 21 CH MONO PLUG-IN HEADBOX | EB NEURO SPA | |
| 5 | 08056446900642 | B8640053000 | Software for EEG, EMG, EP and other applications based on acquiring, processing Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version. | Galileo NT Line Software | EB NEURO SPA | |
| 6 | 08056446900055 | B9630073000 | Patient-interface for EEG ambulatory recorder | BE Micro Headbox | EB NEURO SPA | |
| 7 | 08056446900048 | B9630073300 | Patient-interface for EEG ambulatory recorder | BE Micro PLUG-IN HEADBOX | EB NEURO SPA | |
| 8 | 08056446900024 | B8830073000 | USB interface for EEG ambulatory recorder | BE Micro USB BRIDGE | EB NEURO SPA | |
| 9 | 08056446900017 | B9700073000 | EEG Long Term-Abulatory Recorder | BE Micro Recorder | EB NEURO SPA | |
| 10 | 08056446900000 | B9800073000 | EEG Long Term-Abulatory System | BE Micro | EB NEURO SPA | |
| 11 | 08033928120958 | BRAIN QUICK SOFTWARE | software for acquisition, review, storage , process and measure of biologic sign software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG) | Micromed | MICROMED SPA | |
| 12 | 08033928120910 | BRAIN QUICK | The Micromed BRAIN QUICK system is an integrated acquisition system for physiolo The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) .The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals. | micromed | MICROMED SPA | |
| 13 | 08033928120903 | SD LTM 32 PLUS | long-term EEG fixed and/or ambulatory acquisition/recording device (32 EEG channels) | Micromed | MICROMED SPA | |
| 14 | 08033928120897 | SD LTM 64 PLUS | long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels) | Micromed | MICROMED SPA | |
| 15 | 08033928120880 | SystemPlus EVOLUTION | software for acquisition, review, storage , process and measure of biologic sign software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG) | micromed | MICROMED SPA | |
| 16 | 07290014954007 | Neuro Omega System | NOM-000000-00 | NeuroOmega System | ALPHA OMEGA ENGINEERING CO. LTD. | |
| 17 | 06430056480343 | NM20555X | NM20555N | VectorView HPI coil set Individual OR Package of 1 HPI coil set in a box | HPI coil set (VectorView) | MEGIN OY |
| 18 | 06430056480336 | EL21103J | Auditory Stimulator earphones used with VectorView | Auditory stimulator earphones (VectorView) | MEGIN OY | |
| 19 | 06430056480329 | NM21302N | 124-channel EEG cap (M) used with VectorView | 124-channel cap (M) | MEGIN OY | |
| 20 | 06430056480312 | NM20886N | 60-channel EEG cap (L) used with VectorView | 60-channel cap (L) | MEGIN OY | |
| 21 | 06430056480305 | NM20884N | 60-channel EEG cap (M) used with VectorView | 60-channel cap (M) | MEGIN OY | |
| 22 | 06430056480299 | NM20885N | 60-channel EEG cap (S) used with VectorView | 60-channel cap (S) | MEGIN OY | |
| 23 | 05694110068071 | Acquisition | The Stratus EEG Acquisition is a medical device that is is intended for acquisit The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. | Stratus EEG | KVIKNA MEDICAL EHF. | |
| 24 | 05694110063090 | Acquisition | The Lifelines iEEG Acquisition is a medical device that is is intended for acqui The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well 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. Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system. | Lifelines iEEG | KVIKNA MEDICAL EHF. | |
| 25 | 05694110063083 | KHW2050 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Clinical Desktop System | KVIKNA MEDICAL EHF. | |
| 26 | 05694110063076 | KHW1050 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Yoga Tablet No Video | KVIKNA MEDICAL EHF. | |
| 27 | 05694110063045 | KHW1040 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Laptop System No Video | KVIKNA MEDICAL EHF. | |
| 28 | 05694110063038 | KHW1030 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Laptop System Wireless | KVIKNA MEDICAL EHF. | |
| 29 | 05694110063021 | KHW1010 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Laptop System Wired | KVIKNA MEDICAL EHF. | |
| 30 | 05694110063014 | KHW1022 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Yoga Tablet Wireless | KVIKNA MEDICAL EHF. | |
| 31 | 05694110063007 | KHW1020 | The Lifelines iEEG medical device is intended for acquisition and review of EEG 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. | Lifelines iEEG Portable Yoga Tablet Wired | KVIKNA MEDICAL EHF. | |
| 32 | 05060275450653 | T4A Kit | 2800 | Trackit T4A | LIFELINES LIMITED | |
| 33 | 05060275450646 | T4A | 1600 | Trackit T4A | LIFELINES LIMITED | |
| 34 | 05060275450615 | T4-32 + BT + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
| 35 | 05060275450608 | T4-32 + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
| 36 | 05060275450592 | T4-32 + BT Kit | Trackit T4 | LIFELINES LIMITED | ||
| 37 | 05060275450585 | T4-32 Kit | Trackit T4 | LIFELINES LIMITED | ||
| 38 | 05060275450578 | T4-68 + BT + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
| 39 | 05060275450561 | T4-68 + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
| 40 | 05060275450554 | T4-68 + BT Kit | Trackit T4 | LIFELINES LIMITED | ||
| 41 | 05060275450547 | T4-68 Kit | Trackit T4 | LIFELINES LIMITED | ||
| 42 | 05060275450530 | T4-32 + BT + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
| 43 | 05060275450523 | T4-32 + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
| 44 | 05060275450516 | T4-32 + BT | Trackit T4 | LIFELINES LIMITED | ||
| 45 | 05060275450509 | T4-32 | Trackit T4 | LIFELINES LIMITED | ||
| 46 | 05060275450493 | T4-68 + BT + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
| 47 | 05060275450486 | T4-68 + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
| 48 | 05060275450479 | T4-68 + BT | Trackit T4 | LIFELINES LIMITED | ||
| 49 | 05060275450462 | T4-68 | Trackit T4 | LIFELINES LIMITED | ||
| 50 | 05060275450370 | PP3-S | 1140 | Trackit Battery Box | LIFELINES LIMITED |