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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 - 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

MonitAir - 00860008898005

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
1.1.4
Not in Commercial Distribution

  • 00860008898005 ()


  • Vulnerable patient home-monitoring software, professional-only

eRAD RIS - 00866994000262

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

  • 00866994000262 ()


  • Radiology information system application software

EnsoTherapy - 00864458000421

EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support. Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.
ENSODATA, INC.
6.0
In Commercial Distribution

  • 00864458000421 ()


  • Vulnerable patient home-monitoring software, professional-only

Dentrix Smart Image - 00864058000319

Dental Medical Device Data Systems (MDDS)
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000319 ()


  • Radiology information system application software

ELMED - 00198506001659

GUYON Catheter Guide GUYON cm, 15-1/2"
ELMED INCORPORATED
ST310703939
In Commercial Distribution

  • 00198506001659 ()
ST310703939

  • Robotic surgical system application software
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