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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 - 00860008898074

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

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

maging System HIS-5000U - 08800019600121

imaging system is intended for help observation and recording of eye using a slit lamp
Huvitz Co., Ltd.
HIS-5000U
In Commercial Distribution

  • 08800019600121 ()
HIS-5000U

  • Multidisciplinary medical image management software

TDHisto/Cyto - 03770027519010

TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities. .
TECHNIDATA
TDHisto/Cyto
In Commercial Distribution

  • 03770027519010 ()


  • Pathology information system application software
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