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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.0
In Commercial Distribution

  • 00860991000348 ()


  • Cardiology information system application software
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.4
In Commercial Distribution

  • 00860991000331 ()


  • Cardiology information system application software
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.3
In Commercial Distribution

  • 00860991000324 ()


  • Cardiology information system application software
ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.2.0
In Commercial Distribution

  • 00860991000317 ()


  • Cardiology information system application software
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.1.0
In Commercial Distribution

  • 00860991000300 ()


  • Cardiology information system application software
No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system
No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system
No Description
Philips Medical Systems Hsg
B.01.00
In Commercial Distribution

  • 00884838032408 ()


  • Medical equipment clinical data interfacing software
No Description
Philips Medical Systems Hsg
860343
In Commercial Distribution

  • 00884838030299 ()
860343

  • Electrocardiograph, professional, multichannel
Visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub.
Philips Medical Systems Nederland B.V.
LumiGuide Equipment
In Commercial Distribution

  • 00884838112087 ()
NCVC933

  • Diagnostic x-ray digital imaging system workstation application software
The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.
Philips Medical Systems Nederland B.V.
LumiGuide 3D Hub
In Commercial Distribution

  • 10884838111148 ()
  • 00884838111141 ()

  • Length: 90 Millimeter
  • Lumen/Inner Diameter: 0.035 Inch
LGHN35

  • Luer/Luer linear connector, single-use
The AltaTrack 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with an AltaTrack Guidewire and the AltaTrack Equipment.
Philips Medical Systems Nederland B.V.
AltaTrack 3D Hub
In Commercial Distribution

  • 10884838108582 ()
  • 00884838108585 ()

  • Lumen/Inner Diameter: 0.035 Inch
  • Length: 90 Millimeter
AT3DHNW35

  • Luer/Luer linear connector, single-use
The Information Management System is a software to acquire, display, trend, store, and transmit physiologic, hemodynamic, clinical, medical images, and other related data.
Philips Medical Systems Nederland B.V.
6
In Commercial Distribution

  • 00884838105034 ()
830230

  • Patient health record information system
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.
Philips Medical Systems Nederland B.V.
5
In Commercial Distribution

  • 00884838100084 ()
830230

  • Patient health record information system
Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software
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.
Philips Medical Systems Nederland B.V.
2.6
In Commercial Distribution

  • 00884838098985 ()
98960612834x

  • Patient health record information system
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
Philips Medical Systems Nederland B.V.
733015
Not in Commercial Distribution

  • 00884838095229 ()


  • Cardiac mapping system application software
Philips ST80i Stress System
Philips Medical Systems Hsg
ST80i Stress Test System
In Commercial Distribution

  • 00884838094840 ()
860343

  • Electrocardiograph, professional, multichannel
"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."
Philips Medical Systems Hsg
IntelliSpace ECG Management System
In Commercial Distribution

  • 00884838093478 ()
860426

  • Medical equipment clinical data interfacing software
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.
Philips Medical Systems Nederland B.V.
2.5
In Commercial Distribution

  • 00884838091771 ()
98960612665x

  • Patient health record information system
No Description
Philips Medical Systems Hsg
B.01
In Commercial Distribution

  • 00884838090750 ()


  • Medical equipment clinical data interfacing software
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.
Philips Medical Systems Nederland B.V.
2.4
In Commercial Distribution

  • 00884838087330 ()
98960612482x

  • Patient health record information system
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.
Philips Medical Systems Nederland B.V.
2.3
In Commercial Distribution

  • 00884838085213 ()
98960612322x

  • Patient health record information system
No Description
Philips Medical Systems Nederland B.V.
2.2
In Commercial Distribution

  • 00884838081291 ()
453564649781

  • Patient health record information system
SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522130922 ()
040-1724-01

  • Cardiology information system application software
SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522129773 ()
040-5173-00

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129551 ()
040-1766-00

  • Cardiology information system application software
Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I50330
In Commercial Distribution

  • 08714729229513 ()


  • Cardiovascular ultrasound imaging system
Disposable Pullback Sled for Motordrive
BOSTON SCIENTIFIC CORPORATION
H749A70200
In Commercial Distribution

  • 08714729228684 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100INS0
In Commercial Distribution

  • 08714729119593 ()


  • Cardiovascular ultrasound imaging system
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