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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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eRAD RIS - 00866994000262

eRAD RIS v4.2022
Erad, Inc.
4.22
In Commercial Distribution

  • 00866994000262 ()


  • Radiology information system application software

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

MonitAir - 00860012679256

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
1.2.13
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 - 00860008898098

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
1.2.3
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860008898050

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
1.1.9
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860008898043

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
1.1.8
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860008898036

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
1.1.7
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860008898029

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
1.1.6
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00860008898012

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
1.1.5
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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