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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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The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
No Description
Thought Technology Ltd.
SA9020
In Commercial Distribution

  • 07540191000593 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
Desk to Full Armrest Extension Kit. Armrest Extension tube (insert) to allow longer tube lengths for mounting full length arm pads or to allow for greater arm pad depth adjustment. Mounting hardware included. Kit contains one extension tube
Motion Concepts Inc
D-0123-0128-AEXT
In Commercial Distribution

  • 07540147002893 ()
AEXT

  • Wheelchair armrest
Heavy-Duty 70° Swing Away Legrest Set. Set includes 2 upper down tube assemblies and 2 extension tube assemblies. Hardware included. Three extension tube options/sizes available: 11"-15", 13"-17", 16"-20". Footplates and footplate mounts sold separately.
Motion Concepts Inc
D-0130-HD70
In Commercial Distribution

  • 07540147002855 ()
HD70S

  • Wheelchair footrest/legrest
The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique.
SUN NUCLEAR CORP.
1231410Z
In Commercial Distribution

  • 05060608880201 ()
1231410Z

  • Accelerator system quality assurance device
Quad-Link Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Quad-Link Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-SAQ
In Commercial Distribution

  • 07540147001995 ()
SAQ

  • Wheelchair bracket/mount
The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system.
SUN NUCLEAR CORP.
1231405Z
In Commercial Distribution

  • 05060608880195 ()
1231405Z

  • Accelerator system quality assurance device
PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation
Maxx Resolve Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Resolve Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests
Motion Concepts Inc
D-0181-MR
In Commercial Distribution

  • 07540147001988 ()
MR

  • Wheelchair bracket/mount
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