No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 03615220001200 | 1001-15002-US | 1001-15002-US | GXY | Electrode, Cutaneous | 2 | Neuronaute Dry electrodes | |
2 | 03615220001163 | 1001-01004-US | 1001-01004-US | GWQ | Full-Montage Standard Electroencephalograph | 2 | Neuronaute head S40 | |
3 | 03615220001033 | 1005-00001-US | 1005-00001-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S22 | |
4 | 03615220001057 | 1005-00007-US | 1005-00007-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S30 | |
5 | 03615220001156 | 1005-15003-US | 1005-15003-US | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | Cardioskin Charger | |
6 | 03615220001149 | 1005-15002-US | 1005-15002-US | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | Cardioskin Battery | |
7 | 03615220001125 | 1005-10001-US | 1005-10001-US | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | Cardioskin Recorder | |
8 | 03615220001118 | 1005-00008-US | 1005-00008-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S44 | |
9 | 03615220002573 | 3.3.0 | 1012-21002-US | OUG | Medical Device Data System | 1 | Bioserenity Cloud | |
10 | 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. | GWQ | Full-Montage Standard Electroencephalograph | 2 | Neuronaute 1.2 - Head module |
11 | 03615220001521 | 1.2 | 1001-01010-US | The Neuronaute IceCap is intended to acquire, display, store, and archive EEG si The Neuronaute IceCap 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. | GXY | Electrode, Cutaneous | 2 | Neuronaute IceCap |
12 | 03615220001194 | 1001-10001-US | 1001-10001-US | GWQ | Full-Montage Standard Electroencephalograph | 2 | Neuronaute head module | |
13 | 03615220001217 | 1001-15003-US | 1001-15003-US | GWQ | Full-Montage Standard Electroencephalograph | 2 | Neuronaute battery charger | |
14 | 03615220001088 | 1005-00004-US | 1005-00004-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S41 | |
15 | 03615220001187 | 1001-01006-US | 1001-01006-US | GWQ | Full-Montage Standard Electroencephalograph | 2 | Neuronaute head S44 | |
16 | 03615220001040 | 1005-00006-US | 1005-00006-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S24 | |
17 | 03615220002610 | 2.2.0 | 5100-00012 | OUG | Medical Device Data System | 1 | Neuronaute Application Mobile iOS | |
18 | 03615220001101 | 1005-00005-US | 1005-00005-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S43 | |
19 | 03615220001095 | 1005-00010-US | 1005-00010-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S42 | |
20 | 03615220001071 | 1005-00003-US | 1005-00003-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin textile S34 | |
21 | 03615220001064 | 1005-00002-US | 1005-00002-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S32 | |
22 | 03615220001132 | 1005-15001-US | 1005-15001-US | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | Cardioskin Dock | |
23 | 03615220001026 | 1005-00009-US | 1005-00009-US | DRX | Electrode, Electrocardiograph | 2 | Cardioskin Textile S20 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07290014954007 | Neuro Omega System | NOM-000000-00 | NeuroOmega System | ALPHA OMEGA ENGINEERING CO. LTD. | |
2 | 06430056480343 | NM20555X | NM20555N | VectorView HPI coil set Individual OR Package of 1 HPI coil set in a box | HPI coil set (VectorView) | MEGIN OY |
3 | 06430056480336 | EL21103J | Auditory Stimulator earphones used with VectorView | Auditory stimulator earphones (VectorView) | MEGIN OY | |
4 | 06430056480329 | NM21302N | 124-channel EEG cap (M) used with VectorView | 124-channel cap (M) | MEGIN OY | |
5 | 06430056480312 | NM20886N | 60-channel EEG cap (L) used with VectorView | 60-channel cap (L) | MEGIN OY | |
6 | 06430056480305 | NM20884N | 60-channel EEG cap (M) used with VectorView | 60-channel cap (M) | MEGIN OY | |
7 | 06430056480299 | NM20885N | 60-channel EEG cap (S) used with VectorView | 60-channel cap (S) | MEGIN OY | |
8 | 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. | |
9 | 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. | |
10 | 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. | |
11 | 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. | |
12 | 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. | |
13 | 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. | |
14 | 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. | |
15 | 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. | |
16 | 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. | |
17 | 05060275450653 | T4A Kit | 2800 | Trackit T4A | LIFELINES LIMITED | |
18 | 05060275450646 | T4A | 1600 | Trackit T4A | LIFELINES LIMITED | |
19 | 05060275450615 | T4-32 + BT + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
20 | 05060275450608 | T4-32 + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
21 | 05060275450592 | T4-32 + BT Kit | Trackit T4 | LIFELINES LIMITED | ||
22 | 05060275450585 | T4-32 Kit | Trackit T4 | LIFELINES LIMITED | ||
23 | 05060275450578 | T4-68 + BT + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
24 | 05060275450561 | T4-68 + WI-FI Kit | Trackit T4 | LIFELINES LIMITED | ||
25 | 05060275450554 | T4-68 + BT Kit | Trackit T4 | LIFELINES LIMITED | ||
26 | 05060275450547 | T4-68 Kit | Trackit T4 | LIFELINES LIMITED | ||
27 | 05060275450530 | T4-32 + BT + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
28 | 05060275450523 | T4-32 + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
29 | 05060275450516 | T4-32 + BT | Trackit T4 | LIFELINES LIMITED | ||
30 | 05060275450509 | T4-32 | Trackit T4 | LIFELINES LIMITED | ||
31 | 05060275450493 | T4-68 + BT + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
32 | 05060275450486 | T4-68 + WI-FI | Trackit T4 | LIFELINES LIMITED | ||
33 | 05060275450479 | T4-68 + BT | Trackit T4 | LIFELINES LIMITED | ||
34 | 05060275450462 | T4-68 | Trackit T4 | LIFELINES LIMITED | ||
35 | 05060275450370 | PP3-S | 1140 | Trackit Battery Box | LIFELINES LIMITED | |
36 | 05060275450363 | LI | 1112 | Trackit Battery Box | LIFELINES LIMITED | |
37 | 05060275450356 | PP3 | 1111 | Trackit Battery Box | LIFELINES LIMITED | |
38 | 05060275450349 | Sleep Clickon PCU +SAO2 | 1220 | Trackit PCU | LIFELINES LIMITED | |
39 | 05060275450332 | Short Clickon PCU | 1181 | Trackit PCU | LIFELINES LIMITED | |
40 | 05060275450325 | Trackit 20/4/B Kit | 2120B/BT | Trackit | LIFELINES LIMITED | |
41 | 05060275450318 | Trackit 20/4 Kit | 2120B | Trackit | LIFELINES LIMITED | |
42 | 05060275450301 | Trackit 18/8/B Kit | 2121 B/BT | Trackit | LIFELINES LIMITED | |
43 | 05060275450295 | Trackit 18/8 Kit | 2121B | Trackit | LIFELINES LIMITED | |
44 | 05060275450288 | Trackit 32/0/B Kit | 2122B/BT | Trackit | LIFELINES LIMITED | |
45 | 05060275450271 | Trackit 32/0 Kit | 2122B | Trackit | LIFELINES LIMITED | |
46 | 05060275450264 | Trackit 24/0/B Kit | 2123B/BT | Trackit | LIFELINES LIMITED | |
47 | 05060275450257 | Trackit 24/0 Kit | 2123B | Trackit | LIFELINES LIMITED | |
48 | 05060275450240 | Trackit 12/0/B Kit | 2124B/BT | Trackit | LIFELINES LIMITED | |
49 | 05060275450233 | Trackit 12/0 Kit | 2124B | Trackit | LIFELINES LIMITED | |
50 | 05060275450226 | Trackit 24/8/B Kit | 2125B/BT | Trackit | LIFELINES LIMITED |