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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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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

iLab Ultrasound Imaging System - 08714729777694

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CART0
In Commercial Distribution

  • 08714729777694 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729780205

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CART0
In Commercial Distribution

  • 08714729780205 ()


  • Cardiovascular ultrasound imaging 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

NA - 08714729401094

Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I5033R0
In Commercial Distribution

  • 08714729401094 ()


  • 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

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

iLab Ultrasound Imaging System - 08714729848967

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CARTR0
In Commercial Distribution

  • 08714729848967 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729848905

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INSB0
In Commercial Distribution

  • 08714729848905 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729848899

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INSB0
In Commercial Distribution

  • 08714729848899 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729847892

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120N2710
In Commercial Distribution

  • 08714729847892 ()


  • Cardiovascular ultrasound imaging system

CAM - 00840682110075

CAM 14
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00840682110075 ()


  • Electrocardiograph, professional, single-channel

CAM-USB - 00840682109772

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE V2
In Commercial Distribution

  • 00840682109772 ()


  • Cardiac stress exercise monitoring system

CAM-USB - 00840682109611

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system

CV Web - 00840682107921

CV WEB 3.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3
Not in Commercial Distribution

  • 00840682107921 ()


  • Cardiology information system application software

CardioSoft - 00840682105170

CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution

  • 00840682105170 ()


  • Electrocardiograph, professional, multichannel

CS - 00840682105156

CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution

  • 00840682105156 ()


  • Electrocardiograph, professional, multichannel
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