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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No Description
BIOTRONIK SE & Co. KG
484448
In Commercial Distribution

  • 04035479184445 ()
484448

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
2.7
In Commercial Distribution

  • 04035479183271 ()
482213

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.58
Not in Commercial Distribution

  • 04035479183264 ()
482190

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.57
Not in Commercial Distribution

  • 04035479182045 ()
480113

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.54
Not in Commercial Distribution

  • 04035479177942 ()
472068

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.53
Not in Commercial Distribution

  • 04035479176587 ()
466610

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.50
Not in Commercial Distribution

  • 04035479176143 ()
459761

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.51
Not in Commercial Distribution

  • 04035479175559 ()
462086

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.55
Not in Commercial Distribution

  • 04035479179779 ()
474019

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.49
Not in Commercial Distribution

  • 04035479169466 ()
455929

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.48
Not in Commercial Distribution

  • 04035479168773 ()
453795

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.47
Not in Commercial Distribution

  • 04035479167509 ()
451625

  • Implantable cardiac device management application software
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system
Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468201200
In Commercial Distribution

  • E31584682012000 ()


  • Stationary panoramic dental x-ray system, analogue
Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200500
In Commercial Distribution

  • E31584682005000 ()


  • Stationary panoramic dental x-ray system, analogue
Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200100
In Commercial Distribution

  • E31584682001000 ()


  • Stationary panoramic dental x-ray system, analogue
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
Trucise 2.0 Communication Module
TERUMO BCT, INC.
METCM2
In Commercial Distribution

  • 05020583300088 ()


  • Blood bank information system
Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system
Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system
Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


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

  • 00802526625404 ()
667256-110

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software
Patient Kit
BOSTON SCIENTIFIC CORPORATION
666385-100
In Commercial Distribution

  • 00802526621307 ()
666385-100

  • Implantable cardiac device management application software
For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-100
In Commercial Distribution

  • 00802526621017 ()
667256-100

  • Implantable cardiac device management application software
For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667259-100
In Commercial Distribution

  • 00802526621000 ()
667259-100

  • Implantable cardiac device management application software
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