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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
1.2.6
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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
1.2.4
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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
1.2.5
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Platform for communication with the Volumat MC Agilia infusion pump via a USB cable
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000851831 ()
Z073476

  • Infusion pump medication-dosage application software
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
1.2.7
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.
Philips Medical Systems Nederland B.V.
CT Trueview - 2
In Commercial Distribution

  • 00884838064782 ()
001010

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.
Philips Medical Systems Nederland B.V.
VesselNavigator - 1
In Commercial Distribution

  • 00884838064775 ()
001013

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
AneurysmFlow - 1
In Commercial Distribution

  • 00884838064768 ()
001015

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.
Philips Medical Systems Nederland B.V.
XperCT Dual - 3
In Commercial Distribution

  • 00884838059306 ()
001105

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray.
Philips Medical Systems Nederland B.V.
EmboGuide - 1
In Commercial Distribution

  • 00884838059290 ()
001012

  • Angiographic x-ray system application software
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