Other products from "SPACELABS HEALTHCARE (WASHINGTON), INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10841522127069 96102 96102 XHIBIT CENTRAL STATION,96102 MSX,DSI,MHX,MLD System, network and communication, physiological monitors,DETECTOR AND ALARM, AR System, network and communication, physiological monitors,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM 2 Xhibit
2 10841522124587 90207, 90207A, 90217, 90227,TARSAN N/A UNIVERSAL CUFF COVER LARGE SIZE - BOX OF 50 DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
3 10841522124570 90207, 90207A, 90217, 90227, TARSAN 706-0182-00 UNIVERSAL CUFF COVER STANDARD SIZE - BOX OF 50 DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
4 10841522123177 90227 90227-1 ABP ONTRAK MONITOR, MULTI-LINGUAL DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
5 10841522122996 96501 96501 96501,XHIBIT XC4 MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) 2 Xhibit
6 10841522122460 CD12USB CD12M CARDIODIRECT12M DPS Electrocardiograph 2 CD12
7 10841522122453 CD12USB CD12MI CARDIODIRECT12MI DPS Electrocardiograph 2 CD12
8 10841522122446 CD12USB CD12SENTINEL CARDIODIRECT12, FOR SENTINEL DPS Electrocardiograph 2 CD12
9 10841522122439 CD12US CD12S CARDIODIRECT12S DPS Electrocardiograph 2 CD12
10 10841522108341 90217 N/A 90217/90217A Ultralite ABP Monitor, Ambulatory Blood Pressure DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
11 10841522107832 96102 L-96102 CENTRAL STATION,96102,LOANER MLD,DSI,MHX,MSX MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOG MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS 2 Xhibit
12 10841522107719 90227 L-90227-1 LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
13 10841522107160 96102 N/A Central Station DSI,MSX,MHX,MLD DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MO DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM 2 Xhibit
14 10841522106453 92506 N/A Ambulatory Blood Pressure (ABP) Report Management System DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
15 10841522106446 92506 N/A Ambulatory Blood Pressure (ABP) Report Management System DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
16 10841522105074 90217 N/A Ambulatory Blood Pressure Monitor DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
17 10841522105067 90217 N/A ABP ULTRALITE MONITOR,MULTI-LINGUAL DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 ABP
18 10841522100536 96102 011-0241-01 DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE MSX,MHX SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) 2 Xhibit
19 10841522100345 96102 96102 XHIBIT CENTRAL STATION,96102 MHX,MLD,DSI,MSX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS 2 Xhibit
20 30841522123041 ARIA; SUPPLY 23189-106-401 KIT,HOOK-UP,CASE OF 20,ARIA DSH RECORDER, MAGNETIC TAPE, MEDICAL 2 SPACELABS HEALTHCARE
21 30841522122860 TAY 50-0191 HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20 DSH RECORDER, MAGNETIC TAPE, MEDICAL 2 SPACELABS HEALTHCARE
22 10841522129551 98201 040-1766-00 UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER DQK Computer, diagnostic, programmable 2 Sentinel
23 10841522129537 98000 98000SL PATHFINDER SL ANALYSER DQK Computer, diagnostic, programmable 2 PATHFINDER
24 10841522129414 98200 040-1725-01 SENTINEL 11 RDT TEST SYSTEM DQK Computer, diagnostic, programmable 2 SENTINEL
25 10841522129315 98200 040-1748-01 SENTINEL 11 / PATHFINDER SL KIT FR DQK Computer, diagnostic, programmable 2 SENTINEL
26 10841522129308 98200 040-1724-01 SENTINEL 11 HL7 TEST SYSTEM DQK Computer, diagnostic, programmable 2 SENTINEL
27 10841522129292 98200 040-1723-01 SENTINEL 11 NETWORKED TEST SYSTEM DQK Computer, diagnostic, programmable 2 SENTINEL
28 10841522129285 98200 040-1722-01 SENTINEL 11 STANDALONE TEST SYSTEM DQK Computer, diagnostic, programmable 2 SENTINEL
29 10841522129070 SUPPLY 714-0018-00 NIBP,HOSE ASSY,ADULT,QUICK RELEASE DXN System, measurement, blood-pressure, non-invasive 2 SPACELABS HEALTHCARE
30 10841522129063 91436 91436F FLEXPORT INTERFACE, PB840 VENTILATOR DQA Oximeter 2 SPACELABS HEALTHCARE
31 10841522128752 Supply 685-0037-00 PRE-WIRED NEO ELECTRODES SET,DIN,SPU,3/ST,100/BX DSI DETECTOR AND ALARM, ARRHYTHMIA SPACELABS HEALTHCARE
32 10841522127359 91518; 92518 015-0313-01 SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) SPACELABS HEALTHCARE
33 10841522127342 91518; 92518 015-0312-01 SAMPLE LINE,AGENT,W/SAMPLING TEE,7',50/BX CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) SPACELABS HEALTHCARE
34 10841522127052 90478 040-1429-04 KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) 2 Ultraview
35 10841522126864 90227 90227-2 ABP ONTRAK MONITOR, GERMAN DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 SPACELABS HEALTHCARE
36 10841522105463 90478 MDTM, MV1, DL, ST, UHF MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) 2 Ultraview
37 10841522126857 TARSAN 90217A-2 ABP ULTRALITE MONITOR, GERMAN DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 2 SPACELABS HEALTHCARE
38 10841522126833 91496 700-0906-01 CABLE,SPO2,MASIMO SET,LNCS DQA Oximeter 2 SPACELABS HEALTHCARE
39 10841522126826 91496 700-0792-00 CABLE,SPO2,NELLCOR,OXIMAX DQA Oximeter 2 SPACELABS HEALTHCARE
40 10841522126819 SUPPLY 700-0002-00 CABLE ASSY,SPO2,NELLCOR DFN SENSORS DQA Oximeter 2 SPACELABS HEALTHCARE
41 10841522126444 91517 704-0003-00 ACSRY,ADAPTER,AIRWAY,NEO,REUSE CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
42 10841522126437 91517 704-0002-00 ACSRY,ADAPTER,AIRWAY,ADULT,REUSE CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
43 10841522126420 91517 704-0028 CO2 SAMPLE LINE W/MALE LUER W/NAFION CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
44 10841522126406 91517 704-0026 CO2 AIRWAY ADAPTER W/NAFION, PED/INF CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
45 10841522126390 91517 704-0024 CO2 AIRWAY ADAPTER W/NAFION, PED/ADL CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
46 10841522126376 91517 704-0023 CO2 AIRWAY ADAPTER, PEDIATRIC/ADULT CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
47 10841522126369 91517 704-0022 CO2 ORAL/NASAL CANNULA W/O2, PEDIATRIC CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
48 10841522126352 91517 704-0020 CO2 ORAL/NASAL CANNULA W/O2, ADULT CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
49 10841522105456 90478 MDTM,MV1,ST,UHF 602-608MHZ MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) 2 Ultraview
50 10841522126338 91517 704-0017 CO2 ORAL/NASAL CANNULA, ADULT CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 2 SPACELABS HEALTHCARE
Other products with the same Product Codes "DQK, DXH"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 03770019196007 A001 A001 Cardiac Electrophysiology mapping tool VX1 SUBSTRATE HD
2 03700546706400 HWA09 Withings® WITHINGS
3 03615220001156 1005-15003-US 1005-15003-US Cardioskin Charger BIOSERENITY
4 03615220001149 1005-15002-US 1005-15002-US Cardioskin Battery BIOSERENITY
5 03615220001132 1005-15001-US 1005-15001-US Cardioskin Dock BIOSERENITY
6 03615220001125 1005-10001-US 1005-10001-US Cardioskin Recorder BIOSERENITY
7 00884838105034 6 830230 The Information Management System is a software to acquire, display, trend, stor The Information Management System is a software to acquire, display, trend, store, and transmit physiologic, hemodynamic, clinical, medical images, and other related data. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
8 00884838100084 5 830230 The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
9 00884838099340 AltaTrack equipment 4322 070 2535 X The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. AltaTrack PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
10 00884838098985 2.6 98960612834x The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
11 00884838095229 733015 The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiologic The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP)procedures. The KODEX-EPD™ System provides information about the electrical activity of theheart and about catheter location during the procedure. The system can be used on patients who areeligible for a conventional electrophysiological procedure. KODEX-EPD System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
12 00884838094840 ST80i Stress Test System 860343 Philips ST80i Stress System Stress PHILIPS MEDICAL SYSTEMS HSG
13 00884838093478 IntelliSpace ECG Management System 860426 "Provides for the acquisition, processing, storage, and distribution for resting "Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well as for Philips stress and Holter reports. Non-Philips devices optionally supported. Application software only. Does not include Windows Server 2012 or SQL Server 2014. North America: Includes remote software installation in customer-supplied compliant environment. Base editions and base upgrades include standard implementation. Custom or incremental services are quoted by the SCS or local organization with a Statement of Work. International Markets: Implementation services are not included and are quoted separately." IECG PHILIPS MEDICAL SYSTEMS HSG
14 00884838091771 2.5 98960612665x The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
15 00884838090750 B.01 IECG PHILIPS MEDICAL SYSTEMS HSG
16 00884838087330 2.4 98960612482x The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
17 00884838085213 2.3 98960612322x The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
18 00884838081291 2.2 453564649781 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
19 00884838070721 2.1 453564530681 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
20 00884838070691 1.5 453564495001 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
21 00884838032408 B.01.00 IECG PHILIPS MEDICAL SYSTEMS HSG
22 00884838030299 860343 860343 Philips PHILIPS MEDICAL SYSTEMS HSG
23 00869781000308 Navik 3D v2.0 200-00668 Navik 3D™ is a multi-component computer system that utilizes image processing me Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed.Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care. Navik 3D APN HEALTH
24 00869770000234 K100A101X ZIO SR ECG Monitoring Service ZIO SR Patch IRHYTHM TECHNOLOGIES, INC.
25 00869770000234 K100A101X ZIO SR ECG Monitoring Service ZIO SR Patch IRHYTHM TECHNOLOGIES, INC.
26 00869770000210 A100A100X ZIO AT ECG Monitoring Service ZIO AT Patch IRHYTHM TECHNOLOGIES, INC.
27 00869770000210 A100A100X ZIO AT ECG Monitoring Service ZIO AT Patch IRHYTHM TECHNOLOGIES, INC.
28 00869047000431 4.X.X The VidiStar PACS & DICOM Viewer Software system is a picture archiving and comm The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. VidiStar PACS & DICOM Viewer Software FUJIFILM HEALTHCARE AMERICAS CORPORATION
29 00868282000220 RS-10003 RhythmStar RHYTHMEDIX, LLC
30 00868282000213 RS-10002V RhythmStar RHYTHMEDIX, LLC
31 00868282000206 RS-10002 RhythmStar RHYTHMEDIX, LLC
32 00862887000364 PM461 Decipher Holter Monitor is a small, patient worn device, prescribed by physician Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Decipher Holter Monitor MEDICOMP, INC.
33 00860991000362 6.2 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
34 00860991000355 6.1 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
35 00860991000348 6.0 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Epiphany Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
36 00860991000331 5.4 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Epiphany Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
37 00860991000324 5.3 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Epiphany Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
38 00860991000317 5.2.0 ECG Management System is a software only ECG management database that stores, di ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data Epiphany Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
39 00860991000300 5.1.0 ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data Epiphany Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
40 00860007954177 VMCU1 vMap Control Unit VEKTOR MEDICAL, INC.
41 00860007954108 VMDISP1 vMap Disposables VEKTOR MEDICAL, INC.
42 00860003939734 V2.0 790.102.200 The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm.The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s). AfibAlert / hom ecg+ LOHMAN TECHNOLOGIES, LLC
43 00860003939703 V1.5 790.0102.001 The AfibAlert® is a cardiac event recorder capable of recording and storing ~fiv The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.The device can record a single channel of ECG data in four ways: (I) via the two thumb electrodes, (2) by placement on the chest, (3) by applying wrist electrodes or (4) applying two sticky electrodes as instructed by their physician. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.If AF is indicated, or concerning symptoms are present, the patient can either use a Bluetooth connection to a smart device or use a USB connection to a computer to transfer their ECG data to be viewed and/or shared with their physician. AfibAlert LOHMAN TECHNOLOGIES, LLC
44 00860000272414 RX-1 The Rhythm Express RX-1 will be worn by adult patients for a period of time as p The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network.The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. Rhythm Express VIVAQUANT, INC.
45 00860000272407 RX-1 mini The Rhythm Express RX-1 mini will be worn by adult patients for a period of time The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network.The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. Rhythm Express VIVAQUANT, INC.
46 00857560008010 1.2.5 113-01003 The HealthView ECG Manager is a computer system, used within a clinical network, The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis. HealthView ECG Manager LUMEDX CORPORATION
47 00857553006139 D300 D300 Cardea SOLO PC Software - ECG analysis software (D300) Cardea SOLO CARDIAC INSIGHT, INC.
48 00857553006092 C300/D300 C300/D300 StealthView Software & Smart Cable - ECG analysis software (D300) and data trans StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300). Stealth System S300 CARDIAC INSIGHT, INC.
49 00857335005091 RW2 2 component patch RW2 MyCite Patch OTSUKA AMERICA PHARMACEUTICAL INC
50 00857335005053 DW5 DW5 replacement patch MyCite Patch OTSUKA AMERICA PHARMACEUTICAL INC