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
1.2.2
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
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 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 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 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 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 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 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
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 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 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 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
Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
In Commercial Distribution

  • 05450104548390 ()
991.8346.**

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
In Commercial Distribution

  • 05450104548383 ()
991.8346.**

  • Laboratory refrigerator/freezer
Pharmacy refrigerator/ freezer
B Medical Systems SARL
MP380CS
Not in Commercial Distribution

  • 05450104532450 ()
991.6789.52

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
ML380CS
Not in Commercial Distribution

  • 05450104532443 ()
991.6789.51

  • Laboratory refrigerator/freezer
Pharmacy refrigerator/ freezer
B Medical Systems SARL
MP380CS
In Commercial Distribution

  • 05450104519161 ()
991.6789.**

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
ML380CS
In Commercial Distribution

  • 05450104519154 ()
991.6789.**

  • Laboratory refrigerator/freezer
Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
Not in Commercial Distribution

  • 05450104537721 ()
991.8346.03

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
Not in Commercial Distribution

  • 05450104537714 ()
991.8346.02

  • Laboratory refrigerator/freezer
No Description
Hasa Optix
551199
In Commercial Distribution

  • 05404027402178 ()
  • 05404027417004 ()


  • Intraocular lens folder
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
1.2.7
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
1.2.6
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
1.2.4
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
1.2.5
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Humer Lens Folding Forceps
KRISHNA IMPORTS INC
S5-1804
In Commercial Distribution

  • 00810799035158 ()
S5-1804

  • Intraocular lens folder
GD50DFAT
TOP-RANK HEALTH CARE CO., LTD.
FAF2000
Not in Commercial Distribution

  • 06973602730085 ()
FAF2000

  • Transcranial electrical stimulation system, pulsed-current
No Description
TOP-RANK HEALTH CARE CO., LTD.
50100
Not in Commercial Distribution

  • 06973602730078 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
TOP-RANK HEALTH CARE CO., LTD.
5050
Not in Commercial Distribution

  • 06973602730061 ()


  • Transcranial electrical stimulation system, pulsed-current
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