No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04650075330074 | Focus | 2-channel neurodiagnostic testing system designed to enable reliable recording, 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from thehuman nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. | JXE,IKN | Device, Nerve Conduction Velocity Measurement,Electromyograph, Diagnostic | 2 | Focus | |
2 | 04650075333174 | MEGA-TMS | The device is intended for magnetic stimulation of peripheral nerves. The obtain The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation. | GWF | Stimulator, Electrical, Evoked Response | 2 | MEGA-TMS | |
3 | 04650075330197 | TMS | The Neurosoft TMS system is indicated for the treatment of Major Depressive Dis The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode. | OBP | Transcranial Magnetic Stimulator | 2 | Neurosoft | |
4 | 04650075330081 | CloudEKG | The CloudEKG device is a 12 standard leads battery operated unit intended for The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals.CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device. | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | CloudEKG | |
5 | 04650075330135 | Neuron-Spectrum-4/P | The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurop The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 21EEG channels, up to 4 polygraphic channels ,1 breath channel and 2 direct current channels.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes | GWQ,OLV,OLT | Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electro Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electroencephalograph,Non-Normalizing Quantitative Electroencephalograph Software | 2 | Neuron-Spectrum | |
6 | 04650075330128 | Neuron-Spectrum-4 | The digital systems Neuron-Spectrum-4 are intended for use as digital neurophys The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 21 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes. | GWQ,OLV,OLT | Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electro Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electroencephalograph,Non-Normalizing Quantitative Electroencephalograph Software | 2 | Neuron-Spectrum | |
7 | 04650075330111 | Neuron-Spectrum-3 | The digital systems Neuron-Spectrum-3 are intended for use as digital neurophys The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 19 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes. | GWQ,OLV,OLT | Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electro Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electroencephalograph,Non-Normalizing Quantitative Electroencephalograph Software | 2 | Neuron-Spectrum | |
8 | 04650075330104 | Neuron-Spectrum-2 | The digital systems Neuron-Spectrum-2 are intended for use as digital neurophys The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 16 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes. | GWQ,OLV,OLT | Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electro Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electroencephalograph,Non-Normalizing Quantitative Electroencephalograph Software | 2 | Neuron-Spectrum | |
9 | 04650075330098 | Neuron-Spectrum-1 | The digital systems Neuron-Spectrum-1 are intended for use as digital neurophys The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 8 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes. | GWQ,OLV,OLT | Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electro Full-Montage Standard Electroencephalograph,Standard Polysomnograph With Electroencephalograph,Non-Normalizing Quantitative Electroencephalograph Software | 2 | Neuron-Spectrum | |
10 | 04650075330036 | Neuro-Audio | The Neuro-Audio system is indicated for use in the recording and analysis of hum The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.The patient group includes all ages and genders. | GWJ,EWO | Stimulator, Auditory, Evoked Response,Audiometer | 2 | Neuro-Audio | |
11 | 04650075330371 | Neuro-IOM | Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for in Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status.The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations:I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist. | GWF,GWE,GWJ,OLT,PDQ | Stimulator, Electrical, Evoked Response,Stimulator, Photic, Evoked Response,Stim Stimulator, Electrical, Evoked Response,Stimulator, Photic, Evoked Response,Stimulator, Auditory, Evoked Response,Non-Normalizing Quantitative Electroencephalograph Software,Neurosurgical Nerve Locator | 2 | Neuro-IOM | |
12 | 04650075330296 | CloudTMS | The CloudTMS system is indicated for the treatment of Major Depressive Disorder The CloudTMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode. | OBP | Transcranial Magnetic Stimulator | 2 | CloudTMS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03615220001774 | 1.2 | 1001-10004-US | Neuronaute Head Module is intended to acquire, display, store, and archive EEG s Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician. | Neuronaute 1.2 - Head module | BIOSERENITY |
2 | 03615220001217 | 1001-15003-US | 1001-15003-US | Neuronaute battery charger | BIOSERENITY | |
3 | 03615220001194 | 1001-10001-US | 1001-10001-US | Neuronaute head module | BIOSERENITY | |
4 | 03615220001187 | 1001-01006-US | 1001-01006-US | Neuronaute head S44 | BIOSERENITY | |
5 | 03615220001170 | 1001-01005-US | 1001-01005-US | Neuronaute head S42 | BIOSERENITY | |
6 | 03615220001163 | 1001-01004-US | 1001-01004-US | Neuronaute head S40 | BIOSERENITY | |
7 | EBCI80600 | TD 1.x | cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain acti cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements. | cortiQ PRO | G.TEC MEDICAL ENGINEERING GMBH | |
8 | 00884838051515 | 866421 | 866421 | PHILIPS IntelliVue BIS Module | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
9 | 00884838021105 | 862293 | 862293 | PHILIPS BIS Module | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
10 | 00884838021075 | 862290 | 862290 | PHILIPS EEG Parameter Module | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
11 | 00884838011908 | 989803105661 | 989803105661 | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | |
12 | 00884838011878 | CBL Reusable EEG Pedi Cup Electrodes | 989803105631 | EEG Lead Set Pedi 5 Elec. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
13 | 00884838011861 | Reusable EEG Adult Cup Electrodes | 989803105621 | EEG Lead Set Adult 5 Elec. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
14 | 00869732000142 | App for Web | This is an application intended to be used by neurologists who are monitoring or This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst. | Persyst Mobile App | PERSYST DEVELOPMENT CORP | |
15 | 00869732000135 | App for iOS | This is an application intended to be used by neurologists who are monitoring or This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst. | Persyst Mobile App | PERSYST DEVELOPMENT CORP | |
16 | 00869732000128 | P14 | Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring andtrending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 14 Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
17 | 00869732000111 | P13 | Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 13 EEG Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
18 | 00869732000104 | P12 | Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. | Persyst 12 EEG Review and Analysis Software | PERSYST DEVELOPMENT CORP | |
19 | 00867975000288 | BWMini PSG | PV 2311 | BWMini PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
20 | 00867975000288 | BWMini PSG | PV 2311 | BWMini PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
21 | 00867975000271 | BWMini HST | PV 2312 | BWMini HST: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
22 | 00867975000271 | BWMini HST | PV 2312 | BWMini HST: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
23 | 00867975000264 | BWMini EEG | PV 2310 | BWMini EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
24 | 00867975000264 | BWMini EEG | PV 2310 | BWMini EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
25 | 00867975000257 | BWII PSG Digital | PV 1825 | BWII PSG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
26 | 00867975000257 | BWII PSG Digital | PV 1825 | BWII PSG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
27 | 00867975000240 | BWII EEG Digital | PV 1652 | BWII EEG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
28 | 00867975000240 | BWII EEG Digital | PV 1652 | BWII EEG Digital: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
29 | 00867975000233 | BWIII EEG | PV 2006 | BWIII EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
30 | 00867975000233 | BWIII EEG | PV 2006 | BWIII EEG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
31 | 00867975000226 | BWIII PSG | PV 2008 | BWIII PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
32 | 00867975000226 | BWIII PSG | PV 2008 | BWIII PSG: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
33 | 00867975000219 | BWIII EEG Plus | PV 2007 | BWIII EEG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
34 | 00867975000219 | BWIII EEG Plus | PV 2007 | BWIII EEG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
35 | 00867975000202 | BWIII PSG Plus | PV 2009 | BWIII PSG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
36 | 00867975000202 | BWIII PSG Plus | PV 2009 | BWIII PSG Plus: Full-montage standard electroencephalograph device | Neurovirtual | M F EQUIPAMENTOS MEDICOS LTDA EPP |
37 | 00867606000304 | EVO-002-400-000 | The eVox System is intended for the acquisition, display, and storage, of electr The eVox System is intended for the acquisition, display, and storage, of electrical activityof a patient’s brain including electroencephalograph (EEG) and event-related potentials(ERP) obtained by placing two or more electrodes on the head to aid in diagnosisThe medical system includes the “eVox System” amplifier device, accessories, and acomputer (laptop computer or tablet device with internal battery and power cord).The hardware and ancillary components used in conjunction with the eVox System includean EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, andwall adapter), a Subject Response Device and a Base Station laptop computer. Thesoftware on the Base Station laptop computer is intended for device functioning | eVox System | EVOKE NEUROSCIENCE, INC. | |
38 | 00863003000336 | MCGSN 100 Series | EEG Electrode Array | MicroCel Geodesic Sensor Net | ELECTRICAL GEODESICS, INC. | |
39 | 00863003000329 | HCGSN 130 | EEG Electrode Array | HydroCel Geodesic Sensor Net | ELECTRICAL GEODESICS, INC. | |
40 | 00863003000312 | GPS 3.0 | Full-montage Standard ElectroencephalographCAMERA, SURGICAL AND ACCESSORIES | Geodesic Photogrammetry System | ELECTRICAL GEODESICS, INC. | |
41 | 00863003000305 | GES 400 Series | Electroencephalograph | Geodesic EEG System | ELECTRICAL GEODESICS, INC. | |
42 | 00851420007052 | C100 | Pocket EEG Device | CERIBELL, INC. | ||
43 | 00851420007045 | SW-00001 | Pocket EEG Device, EEG Recording Viewer Software | CERIBELL, INC. | ||
44 | 00851420007038 | C152 | Ceribell EEG Headband, medium size | CERIBELL, INC. | ||
45 | 00851420007021 | C151 | Ceribell EEG Headband, small size | CERIBELL, INC. | ||
46 | 00851420007007 | C100 | Pocket EEG Device | CERIBELL, INC. | ||
47 | 00851113007987 | SP29-1006.LE, SP29-1009.LE | Sleep Profiler PSG2 LE Device Kit - Piezo | Sleep Profiler PSG2 | ADVANCED BRAIN MONITORING, INC. | |
48 | 00851113007970 | SP29-1001.LE, SP29-1008.LE | Sleep Profiler PSG2 LE Device kit - ezRIP | Sleep Profiler PSG2 | ADVANCED BRAIN MONITORING, INC. | |
49 | 00851113007963 | SP29-1002.LE, SP29-1007.LE | Sleep Profiler PSG2 LE Device Kit No Belts (PM3) | Sleep Profiler PSG2 | ADVANCED BRAIN MONITORING, INC. | |
50 | 00851113007956 | SP40-1001.LE, SP29-1003.LE | Sleep Profiler LE Device Kit | Sleep Profiler | ADVANCED BRAIN MONITORING, INC. |