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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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Connection Box - IBI™
BOSTON SCIENTIFIC CORPORATION
M004RA61000
In Commercial Distribution

  • 08714729841753 ()


  • Cardiac mapping system
Connection Box - Stockert™
BOSTON SCIENTIFIC CORPORATION
M004RA60000
In Commercial Distribution

  • 08714729841746 ()


  • Cardiac mapping system
ECG Cable - Chest - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5200US0
In Commercial Distribution

  • 08714729841739 ()


  • Electrocardiographic lead set, reusable
ECG Cable - Limbs - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5100US0
In Commercial Distribution

  • 08714729841715 ()


  • Electrocardiographic lead set, reusable
ECG Cable - Trunk - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5000US0
In Commercial Distribution

  • 08714729841692 ()


  • Electrocardiographic lead set, reusable
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTB0
In Commercial Distribution

  • 08714729838708 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240INS0
In Commercial Distribution

  • 08714729810230 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220INS0
In Commercial Distribution

  • 08714729810223 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220INS0
In Commercial Distribution

  • 08714729810216 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120INS0
In Commercial Distribution

  • 08714729810193 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INS0
In Commercial Distribution

  • 08714729810186 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100INS0
In Commercial Distribution

  • 08714729810179 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTR0
In Commercial Distribution

  • 08714729810155 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTD0
In Commercial Distribution

  • 08714729810148 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CART0
In Commercial Distribution

  • 08714729810131 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CARTD0
In Commercial Distribution

  • 08714729810117 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CART0
In Commercial Distribution

  • 08714729810100 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CARTR0
In Commercial Distribution

  • 08714729810087 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTR0
In Commercial Distribution

  • 08714729810070 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CARTD0
In Commercial Distribution

  • 08714729810063 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTD0
In Commercial Distribution

  • 08714729810056 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CART0
In Commercial Distribution

  • 08714729810049 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CART0
In Commercial Distribution

  • 08714729810032 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CART0
In Commercial Distribution

  • 08714729810025 ()


  • 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
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INS0
In Commercial Distribution

  • 08714729765127 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100CART0
In Commercial Distribution

  • 08714729761235 ()


  • Cardiovascular ultrasound imaging system
Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
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