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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 - 00860008898067

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
1.2.0
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

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

Affymetrix - 00856826006067

No Description
Affymetrix, Inc.
1.2
In Commercial Distribution

  • 00856826006067 ()
610466

  • Laboratory instrument application software IVD

Affymetrix - 00856826006050

No Description
Affymetrix, Inc.
2.1
In Commercial Distribution

  • 00856826006050 ()
610533

  • Laboratory instrument application software IVD

Iradimed - 00856038001157

MRIDIUM 3860 DERS LIBRARY KIT
IRADIMED CORP.
1145
In Commercial Distribution

  • 00856038001157 ()
1145

  • Infusion pump medication-dosage application software
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