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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 - 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

Clarapath™ SectionStar™ - 00860012688944

Automated tissue sectioning and transfer system
Clarapath, Inc.
810-00001
In Commercial Distribution



  • Rotary microtome IVD

MonitAir - 00860012679270

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
1.3.x
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 - 00860012679263

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
1.2.14
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

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 - 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 - 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
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