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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
1.2.12
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
1.2.11
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
1.2.10
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
1.2.9
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
1.2.8
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic.
Mirrorme3d, LLC
MOST
In Commercial Distribution



  • Custom-made orthopaedic/craniofacial surgical guide
Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnostic.
Mirrorme3d, LLC
MTPG
In Commercial Distribution



  • Custom-made orthopaedic/craniofacial surgical guide
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 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
1.2.2
Not 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
1.2.1
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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