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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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LUX-Dx™ Clinic Assistant Mobile Device - 00802526621017

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-100
In Commercial Distribution

  • 00802526621017 ()
667256-100

  • Implantable cardiac device management application software

myLUX™ Mobile Device - 00802526621000

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667259-100
In Commercial Distribution

  • 00802526621000 ()
667259-100

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618215

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618208

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software

CareLink SmartSync™ LINQ II™ Platform Application - 00763000891091

SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software

Device Command Library - 00763000378363

SW 2692 CARELINK DEVICE COMMAND LIBRARY
MEDTRONIC, INC.
2692
In Commercial Distribution

  • 00763000378363 ()


  • Implantable cardiac device management application software

Instrument Command Library - 00763000378356

SW 2691 CARELINK INST COMMAND LIBRARY
MEDTRONIC, INC.
2691
In Commercial Distribution

  • 00763000378356 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504533

SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution

  • 00763000504533 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504526

SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution

  • 00763000504526 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504519

SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software
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