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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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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
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100INS0
In Commercial Distribution

  • 08714729119593 ()


  • Cardiovascular ultrasound imaging system
PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
AE-0001-412
Not in Commercial Distribution

  • 08567500070008 ()
AE-0001-412

  • Cardiac electrophysiology analysis system
Holter prep kit with AA battery cleared with Vision 5LR recorder
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution

  • 10812345029939 ()
  • 20812345029936 ()
  • 30812345029933 ()


  • Electrocardiographic ambulatory recorder
No Description
Biosense Webster Inc
D129707
In Commercial Distribution

  • 10846835009439 ()
D129707

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D129704
In Commercial Distribution

  • 10846835009422 ()
D129704

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128709
In Commercial Distribution

  • 10846835008913 ()
D128709

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128627
Not in Commercial Distribution

  • 10846835008906 ()
D128627

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128623
Not in Commercial Distribution

  • 10846835008890 ()
D128623

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128622
In Commercial Distribution

  • 10846835008883 ()
D128622

  • Electrical-only medical device connection cable, reusable
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