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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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EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034D0
Not in Commercial Distribution

  • 08714729935889 ()
M0042002034D0

  • General-purpose multi-parameter bedside monitor
EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420020340
Not in Commercial Distribution

  • 08714729935872 ()
M00420020340

  • General-purpose multi-parameter bedside monitor
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100CART0
In Commercial Distribution

  • 08714729761235 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INS0
In Commercial Distribution

  • 08714729765127 ()


  • Cardiovascular ultrasound imaging system
No Description
BOSTON SCIENTIFIC CORPORATION
H7495554280
In Commercial Distribution

  • 08714729986089 ()
H7495554280

  • Cardiovascular ultrasound imaging system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping 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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