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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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4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368313 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4X5PBP

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368306 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLS3X4PBP

  • Wheelchair head/trunk support, prefabricated
Matrx-Vi Drop Base. (Standard Skin Protection & Positioning Cushion). Includes hardware. Weight capacity up to 300lb.
Motion Concepts Inc
MB-Vi
In Commercial Distribution

  • 07540147000776 ()
MBwwdd-Vi

  • Foam-filled chair cushion
Matrx Base Drop Hook Hardware (2 pair). Hardware for Matrx-Vi Base Cushions and Matrx Kidabra-Vi Base Cushions. Hooks fit 7/8" or 1" tube diameters. Offset available in 0" (flush), 1" or 2" offset
Motion Concepts Inc
BDH
In Commercial Distribution

  • 07540147000578 ()
BDH

  • Wheelchair back rest positioner
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution

  • 00882916000530 ()


  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution

  • 00882916000523 ()


  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution

  • 00882916000516 ()
v1.x and v2.0

  • CT system application software
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution

  • 00852426007022 ()


  • CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution

  • 00852426007015 ()


  • CT system application software
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