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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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EV1000 PLATFORM
Edwards Lifesciences LLC
EV1000A
In Commercial Distribution

  • 00690103189650 ()

  • MONITOR: HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS), DATABOX: HEIGHT: 145 MM, WIDTH: 206 MM, DEPTH: 64 MM, WEIGHT: 0.9 KG (2.0 LBS)
EV1000A

  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor
CorVista System with CAD Add-On
Analytics for Life Inc.
CorVista System with CAD Add-On
In Commercial Distribution

  • 00869059000436 ()


  • Multiparameter physiologic analysis workstation
CorVista® System with CAD Add-On
Analytics for Life Inc.
10-0020
In Commercial Distribution

  • 00869059000429 ()


  • Multiparameter physiologic analysis workstation
ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14510
In Commercial Distribution

  • 08714729948377 ()


  • Cardiac mapping system
ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14010
In Commercial Distribution

  • 08714729948360 ()


  • Cardiac mapping system
Breakout Box
BOSTON SCIENTIFIC CORPORATION
M004RH11020
In Commercial Distribution

  • 08714729948322 ()


  • Cardiac mapping system
Stimulator Jumper Cable
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS220
In Commercial Distribution

  • 08714729938668 ()
M004RAMMTIPS220

  • Electrical-only medical device connection cable, reusable
Patch Cable
BOSTON SCIENTIFIC CORPORATION
M004RALRCBL20
In Commercial Distribution

  • 08714729938651 ()


  • Electrical-only medical device connection cable, reusable
CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG60
In Commercial Distribution

  • 08714729938620 ()


  • Electrocardiographic lead set, reusable
CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG30
In Commercial Distribution

  • 08714729938613 ()


  • Electrocardiographic lead set, reusable
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