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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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Medical Measurement Systems B.V.
G3-9
In Commercial Distribution

  • 08717775955092 ()


  • Gastroduodenal motility analysis system
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
No Description
Rst- Sanexas
RST-SANEXAS PT
In Commercial Distribution

  • 00860000214049 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
Rst- Sanexas
RST-SANEXAS Basic
In Commercial Distribution

  • 00860000214032 ()


  • Transcranial electrical stimulation system, pulsed-current
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
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
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