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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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Rhythmia™ Mapping System - 08714729841975

Signal Station Kit
BOSTON SCIENTIFIC CORPORATION
M004RH10000
In Commercial Distribution

  • 08714729841975 ()


  • Transducer signal amplifier

Rhythmia™ Mapping System - 08714729841906

Rhythmia Power Supply
BOSTON SCIENTIFIC CORPORATION
M004RAPWR0
In Commercial Distribution

  • 08714729841906 ()


  • Basic power supply, reusable

Rhythmia™ Mapping System - 08714729841890

Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH10
In Commercial Distribution

  • 08714729880851 ()
  • 08714729841890 ()


  • Cardiac mapping system reference patch

Rhythmia™ Mapping System - 08714729841883

Male to Male Tip-Jacks 2-2 Pin
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS20
In Commercial Distribution

  • 08714729841883 ()


  • Electrical-only medical device connection cable, single-use

Rhythmia™ Mapping System - 08714729841876

Male to Male Tip-Jacks 16-16 Pin
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS160
In Commercial Distribution

  • 08714729841876 ()


  • Electrical-only medical device connection cable, single-use

Rhythmia™ Mapping System - 08714729841869

Location Reference Cable
BOSTON SCIENTIFIC CORPORATION
M004RALRCBL10
In Commercial Distribution

  • 08714729841869 ()


  • Electrical-only medical device connection cable, single-use

Rhythmia™ Mapping System - 08714729841838

Conditioning Box
BOSTON SCIENTIFIC CORPORATION
M004RACONDITION0
In Commercial Distribution

  • 08714729841838 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841791

Localization Unit Data Cable
BOSTON SCIENTIFIC CORPORATION
M004RA72000
In Commercial Distribution

  • 08714729841791 ()


  • Electrical-only medical device connection cable, single-use

Rhythmia™ Mapping System - 08714729841777

Sensor Interface Unit (SIU) Split Cable
BOSTON SCIENTIFIC CORPORATION
M004RA70000
In Commercial Distribution

  • 08714729841777 ()


  • Electrical-only medical device connection cable, single-use

Rhythmia™ Mapping System - 08714729841760

Connection Box - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62000
In Commercial Distribution

  • 08714729841760 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841753

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

  • 08714729841753 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841746

Connection Box - Stockert™
BOSTON SCIENTIFIC CORPORATION
M004RA60000
In Commercial Distribution

  • 08714729841746 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841739

ECG Cable - Chest - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5200US0
In Commercial Distribution

  • 08714729841739 ()


  • Electrocardiographic lead set, reusable

Rhythmia™ Mapping System - 08714729841715

ECG Cable - Limbs - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5100US0
In Commercial Distribution

  • 08714729841715 ()


  • Electrocardiographic lead set, reusable

Rhythmia™ Mapping System - 08714729841692

ECG Cable - Trunk - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5000US0
In Commercial Distribution

  • 08714729841692 ()


  • Electrocardiographic lead set, reusable

iLab Ultrasound Imaging System - 08714729838708

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTB0
In Commercial Distribution

  • 08714729838708 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810230

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240INS0
In Commercial Distribution

  • 08714729810230 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810223

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220INS0
In Commercial Distribution

  • 08714729810223 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810216

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220INS0
In Commercial Distribution

  • 08714729810216 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810193

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120INS0
In Commercial Distribution

  • 08714729810193 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810186

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INS0
In Commercial Distribution

  • 08714729810186 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810179

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100INS0
In Commercial Distribution

  • 08714729810179 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810155

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTR0
In Commercial Distribution

  • 08714729810155 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810148

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTD0
In Commercial Distribution

  • 08714729810148 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810131

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CART0
In Commercial Distribution

  • 08714729810131 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810117

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CARTD0
In Commercial Distribution

  • 08714729810117 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810100

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CART0
In Commercial Distribution

  • 08714729810100 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810087

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CARTR0
In Commercial Distribution

  • 08714729810087 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810070

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTR0
In Commercial Distribution

  • 08714729810070 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810063

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CARTD0
In Commercial Distribution

  • 08714729810063 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810056

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTD0
In Commercial Distribution

  • 08714729810056 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810049

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL120CART0
In Commercial Distribution

  • 08714729810049 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729810032

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CART0
In Commercial Distribution

  • 08714729810032 ()


  • Cardiovascular ultrasound imaging system

iLab™ - 08714729810025

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CART0
In Commercial Distribution

  • 08714729810025 ()


  • Cardiovascular ultrasound imaging system

Pure EP - 08567500070008

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

iLab Ultrasound Imaging System - 08714729765127

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INS0
In Commercial Distribution

  • 08714729765127 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729761235

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100CART0
In Commercial Distribution

  • 08714729761235 ()


  • Cardiovascular ultrasound imaging system

Holter Analysis Software - M581NEMK1630

Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1620

Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1610

Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
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