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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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Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH20
In Commercial Distribution

  • 00191506000813 ()
M004RAPATCH20

  • Cardiac mapping system reference patch
Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.
SMART SOLUTIONS TECHNOLOGIES SL
1935
In Commercial Distribution

  • 08437011759092 ()
1935

  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
MICROPORT CRM SRL
UPGRADE TO SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527015040 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
NETWORK LICENCE V3,10 USB
In Commercial Distribution

  • 08031527015033 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
V3.10 UPG TO USB COM
In Commercial Distribution

  • 08031527014944 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
V3.10 Network Lic.USB
In Commercial Distribution

  • 08031527014913 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527014289 ()


  • Electrocardiographic long-term ambulatory recording analyser
No Description
MICROPORT CRM SRL
V3.10
In Commercial Distribution

  • 08031527013435 ()


  • Electrocardiographic long-term ambulatory recording analyser
Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel
Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel
MCG Analysis API (Dedicated Server or Software-as-a-Service)
PREMIER HEART, LLC
MCGS
In Commercial Distribution

  • B320MCGS0 ()


  • Cardiopulmonary physiological parameter analysis software
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution

  • B320MCGC0 ()


  • Cardiopulmonary physiological parameter analysis software
DICOM ECG Viewer/Editor
Cordiana Medical Informatics AG
0160100
In Commercial Distribution

  • 07649988821110 ()


  • Cardiology information system application software
ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021532 ()
03417

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM SOFTWARE - 220 V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021525 ()
03416

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL INFLOW SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms waveform calculations. Study results are used by the clinician to assess peripheral vascular function in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021518 ()
03415

  • Peripheral vascular haemodynamic measurement application software
SOFTWARE INTERFACE BOX - An electrically-powered hardwired interface between one or multiple physiologic devices and a connected computer with dedicated physiologic software. The interface receives waveform and pressure data and formats the data before sending it to the computer. The interface also receives signals from the computer to activate a connected physiologic device. The device does not store data after it is sent to the computer.
D.E.HOKANSON, INC.
IB4
In Commercial Distribution

  • 00817065021174 ()
00725

  • Medical networking interface unit
SOFTWARWE- DICOM EXTENSION OPTION - Provides capability for storing NIVP3 patient data in a DICOM system.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021167 ()
05072

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021150 ()
03413

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021143 ()
03412

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL INFLOW SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms waveform calculations. Study results are used by the clinician to assess peripheral vascular function in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021136 ()
03411

  • Peripheral vascular haemodynamic measurement application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
11098-002-50
In Commercial Distribution

  • 00812345029994 ()


  • Patient health record information system application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
92601H-004
In Commercial Distribution

  • 00812345029970 ()


  • Patient health record information system application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
H50-71
In Commercial Distribution

  • 00812345029802 ()


  • Patient health record information system application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-5
In Commercial Distribution

  • 00812345027082 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-2
In Commercial Distribution

  • 00812345027075 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-1
In Commercial Distribution

  • 00812345027068 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-0
In Commercial Distribution

  • 00812345027051 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
11095-002-61
In Commercial Distribution

  • 00812345024784 ()


  • Patient health record information system application software
The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Schiller AG
0.282200
In Commercial Distribution

  • 07613365003758 ()
0.282200

  • Electrocardiographic long-term ambulatory recording analyser application software
RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system
RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system
USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system
RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system
Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system
The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.7 Global
In Commercial Distribution

  • 04250903202520 ()
2092504-270

  • Electrocardiographic ambulatory recorder
The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.6 Global
In Commercial Distribution

  • 04250903202469 ()
2092504-260

  • Electrocardiographic ambulatory recorder
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
Global SP04
In Commercial Distribution

  • 04250903202445 ()
2092504-254

  • Electrocardiographic ambulatory recorder
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