Other products from "BIOSERENITY"
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 03615220001125 1005-10001-US 1005-10001-US DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 Cardioskin Recorder
7 03615220001118 1005-00008-US 1005-00008-US DRX Electrode, Electrocardiograph 2 Cardioskin Textile S44
8 03615220002573 3.3.0 1012-21002-US OUG Medical Device Data System 1 Bioserenity Cloud
9 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
10 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
11 03615220001194 1001-10001-US 1001-10001-US GWQ Full-Montage Standard Electroencephalograph 2 Neuronaute head module
12 03615220001170 1001-01005-US 1001-01005-US GWQ Full-Montage Standard Electroencephalograph 2 Neuronaute head S42
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
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6 00840682112406 HD CAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
7 00840682105071 2000 MAC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8 00840682104838 5500 HD MAC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9 00840682104791 3500 MAC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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36 B287ECG01U0 ECG01-U ECG01-Universal The ECG Check is intended for self-testing by patients at home. This 1-leadcardi The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor allows remote patients to display and transmit their EGG data tomedical professionals via a communication device to a remote server.Specifically, the EGG Check is indicated for patients who are concerned abouttheir heart rhythm and have experienced the following symptoms that aresuggestive of abnormal heart rhythms:* Skipped Beats* Pounding Heart (Palpitations)* Heart Racing or Irregular Pulse* Lightheadedness or Faintness* History of ArrhythmiasPrescription ECG Check CARDIAC DESIGNS INC.
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38 B210AC0190 AC-019 KardiaMobile 6L ALIVECOR, INC.
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40 B147PACETRAKSPEAKS0 Pacetrak Plus rev 4 (PP4-Pacetrak Plus Speaks) Transmitters and Receivers, Electrocardiograph, Telephone Pacetrak Plus rev 4 UNIVERSAL MEDICAL, INC.
41 B147PACETRAKPLUSENR0 Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR) Transmitters and Receivers, Electrocardiograph, Telephone Pacetrak Plus Rev 5 UNIVERSAL MEDICAL, INC.
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44 B147HTSM50 Heartrak Smart Rev 5 Transmitters and Receivers, Electrocardiograph, Telephone Heartrak Smart Rev 5 UNIVERSAL MEDICAL, INC.
45 B147HTECAT020 Heartrak ECAT 2 Transmitters and Receivers, Electrocardiograph, Telephone Heartrak ECAT 2 UNIVERSAL MEDICAL, INC.
46 B147HTECAT010 Heartrak ECAT Transmitters and Receivers, Electrocardiograph, Telephone Heartrak ECAT UNIVERSAL MEDICAL, INC.
47 B147HT20 Heartrak 2 Telephone electrocardiograph transmitter and receiver Heartrak 2 UNIVERSAL MEDICAL, INC.
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