| 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 | 04650075333211 | CloudEEG | The digital systems CloudEEG are intended for use as digital neurophysiological The digital systems CloudEEG 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 10 | 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 | |
| 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 | 00732094247145 | 901031 | 39500-NP-TE | TEOAE HEARING SCRNER SET W O PRINTER | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 2 | 00732094247138 | 901031 | 39500-TE | TEOAE HEARING SCRNER SET INC PRINTER | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 3 | 00732094237979 | 901031 | 39500-NP | Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit—3mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50- 60 Hz AC, Lithium-Ion Integrated Battery, IEC Plug Type-B, -C, - G, and -I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 4 | 00732094237962 | 901031 | 39500 | Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit—3mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50- 60 Hz AC, Lithium-Ion Integrated Battery, IEC Plug Type-B, -C, -G, and -I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 5 | 00732094237047 | 901122 | 39405 | Welch Allyn OAE Hearing Screener Power Supply Accessory | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 6 | 00732094233643 | 901001 | 39513 | OAE HEARING SCREENER CHARGING CRADLE | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 7 | 00732094233629 | 901031 | 39501 | OAE HEARING SCREENER ONLY | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 8 | 00732094199505 | 901001 | 39421 | Welch Allyn Probe Tubes for OAE Hearing Screener; Qty. 100 | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 9 | 00732094199420 | 901031 | 39400-NP | Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 10 | 00732094186338 | 901001 | 39420 | Welch Allyn Single Use Ear Tip Starter Kit for OAE Hearing Screener; Qty. 10 eac Welch Allyn Single Use Ear Tip Starter Kit for OAE Hearing Screener; Qty. 10 each: 7 mm to 15 mm, 3-5 mm and 5-8 mm Flanged; Qty. 30 Probe Tubes; Qty. 140 | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 11 | 00732094186314 | 901122 | 39416 | Welch Allyn Battery Pack for MPT-II Thermal Printer; Lithium-Ion | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 12 | 00732094186215 | 901031 | 39400 | Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100-240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 13 | 00732094185935 | 901001 | 39410 | Welch Allyn MPT-II Thermal Printer for OAE Hearing Screener; Bluetooth Wireless Welch Allyn MPT-II Thermal Printer for OAE Hearing Screener; Bluetooth Wireless Connectivity, Printer Paper (#39412) Qty. 2; 100-240 V, 50-60 Hz AC, Lithium-Ion (#39416) Battery; IEC Plug Type-B, -C, -G, and -I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 14 | 00732094185911 | 901001 | 39413 | Welch Allyn Charging Stand for OAE Hearing Screener | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 15 | 00732094145014 | 901035 | 92600 | Welch Allyn AudioScope 3 Screening Audiometer; Recording Forms (Qty. 25), AudioS Welch Allyn AudioScope 3 Screening Audiometer; Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 110-130 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-B | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 16 | 00732094144970 | 901035 | 92680 | Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording For Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 110-130 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-B | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 17 | 00732094144963 | 901035 | 92682 | Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording For Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 220-240 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 18 | 00732094144956 | 901035 | 92684 | Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording For Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 230-250 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-G | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 19 | 00732094144949 | 901035 | 92686 | Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording For Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 230-250 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-I | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 20 | 00732094106343 | 901035 | 92682S | Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording For Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 220-240 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 21 | 00732094085044 | 901035 | 23300 | Welch Allyn AudioScope 3 Screening Audiometer; Instrument Handle Only, AudioSpec Welch Allyn AudioScope 3 Screening Audiometer; Instrument Handle Only, AudioSpec Ear Speculum Set (#23400); Nickel-Cadmium (#72300) Battery | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 22 | 00732094085037 | 901035 | 23301 | Welch Allyn AudioScope 3 Screening Audiometer; Instrument Handle Only; Nickel-Ca Welch Allyn AudioScope 3 Screening Audiometer; Instrument Handle Only; Nickel-Cadmium (#72300) Battery | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 23 | 00732094081527 | 901031 | 29400 | Welch Allyn OAE Hearing Screener; 100-240 V, 50-60 Hz AC, Lithium-Ion IEC Plug Type-B | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 24 | 00732094012651 | 901035 | 23301-L | LOANER AUDIOSCOPE 3 HANDLE ONLY | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 25 | 00643169861459 | 945NCCPULO | COMPUTER 945NCCPULO LOANER NOTEBOOK | NIM Eclipse | MEDTRONIC XOMED, INC. | |
| 26 | 00643169793880 | 945OPM660LO | MODULE 945OPM660LO LOANER PATIENT | NIM Eclipse | MEDTRONIC XOMED, INC. | |
| 27 | 00643169793866 | 945EEX901LO | STIMULATOR 945EEX901LO LOANER EXTENDER | NIM Eclipse | MEDTRONIC XOMED, INC. | |
| 28 | 00643169793859 | 945ECLCLO | CONTROLLER 945ECLCLO LOANER ECLIPSE | NIM Eclipse | MEDTRONIC XOMED, INC. | |
| 29 | 00643169793842 | 945DAQ916LO | PREAMPLIFIER 945DAQ916LO LOANER DIGITAL | NIM Eclipse | MEDTRONIC XOMED, INC. | |
| 30 | 00643169786653 | ECLC | CONTROLLER ECLC ECLIPSE ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 31 | 00643169553071 | 945NCCPULO | COMPUTER 945NCCPULO LOANER NOTEBOOK | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 32 | 00643169553057 | 945OPM660LO | MODULE 945OPM660LO LOANER PATIENT | NA | MEDTRONIC XOMED, INC. | |
| 33 | 00643169553040 | 945EEX901LO | STIMULATOR 945EEX901LO LOANER EXTENDER | NA | MEDTRONIC XOMED, INC. | |
| 34 | 00643169553033 | 945ECLCLO | CONTROLLER 945ECLCLO LOANER ECLIPSE | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 35 | 00643169553026 | 945DAQ916LO | PREAMPLIFIER 945DAQ916LO LOANER DIGITAL | NA | MEDTRONIC XOMED, INC. | |
| 36 | 00643169523548 | 945CUSB100 | CABLE 945CUSB100 CONTROLLER USB JUMPER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
| 37 | 00643169468573 | NCCPU | COMPUTER NCCPU NOTEBOOK E6540 ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 38 | 00643169378490 | MDP201 | PROBE MDP201 MUTE DETECTOR ROHS | NA | MEDTRONIC XOMED, INC. | |
| 39 | 00643169378483 | EEX901 | STIMULATOR EEX901 EXTENDER ROHS | NA | MEDTRONIC XOMED, INC. | |
| 40 | 00643169378476 | DAQ916 | PREAMPLIFIER DAQ916 DIGITAL ROHS | NA | MEDTRONIC XOMED, INC. | |
| 41 | 00643169378469 | ECLC | CONTROLLER ECLC ECLIPSE ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 42 | 00643169378452 | SPK1004 | PROBE SPK1004 SURGEON CONTROLLED ROHS | NA | MEDTRONIC XOMED, INC. | |
| 43 | 00643169246003 | 945SYSLO | LOANER SYSTEM 945SYSLO NIM ECLIPSE | NIM-ECLIPSE | MEDTRONIC XOMED, INC. | |
| 44 | 00643169221000 | NWCPU | COMPUTER NWCPU DESKTOP ENGLISH ROHS | NIM-Eclipse® | MEDTRONIC XOMED, INC. | |
| 45 | 00643169177710 | NCCPU | COMPUTER NCCPU NOTEBOOK ROHS | NIM-ECLIPSE® | MEDTRONIC XOMED, INC. | |
| 46 | 00643169072053 | 945CUSB100 | CABLE 945CUSB100 CONTROLLER USB JUMPER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
| 47 | 00643169071933 | 945DAQ916 | AMPLIFIER 945DAQ916 DIG PREAMPLIFIER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
| 48 | 00643169071773 | 945AE102 | EARPHONES 945AE102 INSERT | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
| 49 | 00643169071759 | 945CDAQ916 | CABLE 945CDAQ916 PREAMPLIFIER | N/A | MEDTRONIC SOFAMOR DANEK, INC. | |
| 50 | 00643169071742 | 945CEEX20 | CABLE 945CEEX20 20FT STIMULATOR | N/A | MEDTRONIC SOFAMOR DANEK, INC. |