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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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No Description
ICU MEDICAL, INC.
2194
In Commercial Distribution

  • 15019517081275 ()
21-2194-0402-25

  • Infusion pump medication-dosage application software
No Description
MEDIVR, K.K.
MK1
In Commercial Distribution

  • 14580652420010 ()


  • Biomechanical function analysis/rehabilitation software
No Description
LEXI CO., LTD.
Ver.14.0.4.1
In Commercial Distribution

  • 14573443600029 ()


  • Orthopaedic/craniofacial implantation planning software
67-2586-0100-01 is an electronic file. There is no packaging.
ICU MEDICAL, INC.
67-2586-0100-01
In Commercial Distribution

  • 15019517130928 ()

  • Outer Diameter: 0 Millimeter
  • Length: 0 Millimeter
  • Width: 0 Millimeter
  • Circumference: 0 Millimeter
  • 0
  • Depth: 0 Millimeter


  • Infusion pump medication-dosage application software
eRAD RIS v3.2018
Erad, Inc.
3.18
In Commercial Distribution

  • 00866994000248 ()


  • Radiology information system application software
eRAD RIS v2.2016
Erad, Inc.
2.16
In Commercial Distribution

  • 00866994000231 ()


  • Radiology information system application software
Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000469 ()


  • Sleep disorder interpretive software, professional-only
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000452 ()


  • Sleep disorder interpretive software, professional-only
Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
7.0
Not in Commercial Distribution

  • 00864458000445 ()


  • Sleep disorder interpretive software, professional-only
Client site located software application that receives IAD-generated data and provides the mechanism by which patient information is transferred to the Application Server (UltraLinq) via internet.
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
UP_001
In Commercial Distribution

  • 00862894000319 ()


  • Multidisciplinary medical image management software
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