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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™ - 08714729810025

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CART0
In Commercial Distribution

  • 08714729810025 ()


  • Cardiovascular ultrasound imaging system

NA - 08714729401094

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

  • 08714729401094 ()


  • 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 - 08714729777694

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CART0
In Commercial Distribution

  • 08714729777694 ()


  • Cardiovascular ultrasound imaging system

NA - 08714729229513

Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I50330
In Commercial Distribution

  • 08714729229513 ()


  • Cardiovascular ultrasound imaging system

NA - 08714729228684

Disposable Pullback Sled for Motordrive
BOSTON SCIENTIFIC CORPORATION
H749A70200
In Commercial Distribution

  • 08714729228684 ()


  • Cardiovascular ultrasound imaging system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

MDU5 PLUS - 08714729842309

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUSR0
In Commercial Distribution

  • 08714729842309 ()


  • Cardiovascular ultrasound imaging system

Rhythmia™ Mapping System - 08714729842118

Rhythmia Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40000
In Commercial Distribution

  • 08714729842118 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842101

Sensor Interface Unit (SIU)
BOSTON SCIENTIFIC CORPORATION
M004RH22000
In Commercial Distribution

  • 08714729842101 ()


  • Electromagnetic surgical navigation device tracking system

Rhythmia™ Mapping System - 08714729842095

System Control Unit (SCU)
BOSTON SCIENTIFIC CORPORATION
M004RH21000
In Commercial Distribution

  • 08714729842095 ()


  • Electromagnetic surgical navigation device tracking system

Rhythmia™ Mapping System - 08714729842088

Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20000
In Commercial Distribution

  • 08714729842088 ()


  • Electromagnetic surgical navigation device tracking system

Rhythmia™ Mapping System - 08714729842026

Breakout Box MAP Out
BOSTON SCIENTIFIC CORPORATION
M004RH13000
In Commercial Distribution

  • 08714729842026 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842002

Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system

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

iLab Ultrasound Imaging System - 08714729838708

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTB0
In Commercial Distribution

  • 08714729838708 ()


  • Cardiovascular ultrasound imaging system

MDU5 PLUS - 08714729842279

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUS0
In Commercial Distribution

  • 08714729842279 ()


  • Cardiovascular ultrasound imaging system

Rhythmia™ Mapping System - 08714729842057

Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15000
In Commercial Distribution

  • 08714729842057 ()


  • Foot-switch, electrical

Rhythmia™ Mapping System - 08714729842033

ECG Box Out - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RH14000
In Commercial Distribution

  • 08714729842033 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842019

Breakout Box B Out
BOSTON SCIENTIFIC CORPORATION
M004RH12500
In Commercial Distribution

  • 08714729842019 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841999

Breakout Box A Out
BOSTON SCIENTIFIC CORPORATION
M004RH11500
In Commercial Distribution

  • 08714729841999 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841982

Breakout Box A In
BOSTON SCIENTIFIC CORPORATION
M004RH11000
In Commercial Distribution

  • 08714729841982 ()


  • Cardiac mapping system

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 - 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™ - 08714729810131

Cart System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CART0
In Commercial Distribution

  • 08714729810131 ()


  • Cardiovascular ultrasound imaging system

Rhythmia™ Mapping System - 08714729863199

Rhythmia Global Install Bundle
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL10
In Commercial Distribution

  • 08714729863199 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729907060

IntellaNav™ CB - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62500
In Commercial Distribution

  • 08714729907060 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729905899

ECG Out Box and Cable Kit 1 US
BOSTON SCIENTIFIC CORPORATION
M004RB5000US0
In Commercial Distribution

  • 08714729905899 ()


  • Cardiac mapping system
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