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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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Home Monitoring Service Center - 04035479177942

No Description
BIOTRONIK SE & Co. KG
3.54
Not in Commercial Distribution

  • 04035479177942 ()
472068

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479176587

No Description
BIOTRONIK SE & Co. KG
3.53
Not in Commercial Distribution

  • 04035479176587 ()
466610

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479176143

No Description
BIOTRONIK SE & Co. KG
3.50
Not in Commercial Distribution

  • 04035479176143 ()
459761

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479175559

No Description
BIOTRONIK SE & Co. KG
3.51
Not in Commercial Distribution

  • 04035479175559 ()
462086

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479169466

No Description
BIOTRONIK SE & Co. KG
3.49
Not in Commercial Distribution

  • 04035479169466 ()
455929

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479168773

No Description
BIOTRONIK SE & Co. KG
3.48
Not in Commercial Distribution

  • 04035479168773 ()
453795

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479167509

No Description
BIOTRONIK SE & Co. KG
3.47
Not in Commercial Distribution

  • 04035479167509 ()
451625

  • Implantable cardiac device management application software

SynGen® DataTrak - B039SGI07770

The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
Thermogenesis Corp.
SGI-0777
In Commercial Distribution

  • B039SGI07770 ()


  • Blood centrifugation system application software

LUX-Dx™ - 00802526625404

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-110
In Commercial Distribution

  • 00802526625404 ()
667256-110

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623110

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
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