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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 - 00860012679249

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
1.2.12
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860012679232

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
1.2.11
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860012679225

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
1.2.10
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860012679218

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
1.2.9
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860012679201

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
1.2.8
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

TRAQinform Reports - 00860007104947

TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files.
Aiq Global, Inc.
1
In Commercial Distribution

  • 00860007104947 ()


  • Radiology information system application software

TRAQinform Preprocessor - 00860007104923

The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform quality checks, organize, and convert images from DICOM into other file formats including but not limited to Nearly Raw Raster Data (NRRD) format.
Aiq Global, Inc.
1
In Commercial Distribution

  • 00860007104923 ()


  • Radiology information system application software

ELMED - 00198506058103

CYSTO GRID MARKER STAINLESS STEEL
ELMED INCORPORATED
83-31000-CC
In Commercial Distribution

  • 00198506058103 ()
83-31000-CC

  • Robotic surgical system application software

MonitAir - 00198715136333

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

VISU360 - 04250668606748

N/A
Carl Zeiss Vision GmbH
000000-1011-377
Not in Commercial Distribution

  • 04250668606748 ()
000000-1011-377

  • Multidisciplinary medical image management software
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