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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
1.1.4
Not in Commercial Distribution

  • 00860008898005 ()


  • Vulnerable patient home-monitoring software, professional-only
The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements.
NeckCare Holding ehf
v1.1
In Commercial Distribution



  • Biomechanical function analysis/rehabilitation software
SafeID 2.3
VISION RT LIMITED
SafeID 2.3
In Commercial Distribution

  • 05056190500801 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
Pole
Not in Commercial Distribution

  • 05056190500467 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeID Kiosk Box
Not in Commercial Distribution

  • 05056190500450 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeID Kiosk
In Commercial Distribution

  • 05056190500429 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeID Server WebAPI
In Commercial Distribution

  • 05056190500412 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeID 2.1
In Commercial Distribution

  • 05056190500405 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeRT-ID (with interlock)
Not in Commercial Distribution

  • 05056190500382 ()


  • Patient-administration information system application software
No Description
VISION RT LIMITED
SafeRT-ID (no interlock)
Not in Commercial Distribution

  • 05056190500375 ()


  • Patient-administration information system application software
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