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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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Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-001-70
In Commercial Distribution

  • 00817655020105 ()


  • Electrocardiography telemetric monitoring system
Site~Rite 8 Ultrasound System Software
Bard Access Systems, Inc.
SR8v1.0.3
In Commercial Distribution

  • 00801741121449 ()
SR8v1.0.3

  • General-purpose ultrasound imaging system
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD
Software upgrade for Coroventis CoroFlow System
COROVENTIS Research AB
12000-20
In Commercial Distribution

  • 07350111070663 ()


  • Cardiac catheterization laboratory computer
Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system
Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system
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