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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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MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution

  • 00860001700176 ()


  • Footstool
  • Flat panel x-ray detector/film cassette weight-bearing protector
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Small)
PT. SINTONG UNIGOLDEN GLOVE
X - Small
In Commercial Distribution

  • 18994452290029 ()
  • 08994452290022 ()
  • 08994452290084 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Large)
PT. SINTONG UNIGOLDEN GLOVE
X - Large
In Commercial Distribution

  • 18994452290067 ()
  • 08994452290060 ()
  • 08994452290121 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution

  • G554LVIC0 ()


  • Radiology DICOM image processing application software
A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
SUNRISE MEDICAL (US) LLC
QS5 X
In Commercial Distribution

  • 00016958059526 ()
EIF7

  • Push-rim manual wheelchair, non-bariatric
Non-powdered patient examination gloves
C&A Marketing, Inc.
X Large
In Commercial Distribution

  • 00843812168458 ()
  • 10843812168455 ()
WVEBNGXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.1.x
In Commercial Distribution

  • 04262459510028 ()


  • Diagnostic x-ray digital imaging system workstation application software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.0.x
Not in Commercial Distribution

  • 04262459510011 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
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