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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JAZZ HP GREEN STATE POLISHER GS1S ULTRA FINE WHITE CONTOUR MINI 7X19MM - 3 PACK
Ss White Burs, Inc.
U89186
In Commercial Distribution

  • D690891860 ()
  • D690891862 ()
89186

  • Dental abrasive point, single-use
JAZZ HP GREEN STATE POLISHER GS1S ULTRA FINE WHITE CONTOUR MAXI 10X22.7MM - 3 PACK
Ss White Burs, Inc.
U89185
In Commercial Distribution

  • D690891850 ()
  • D690891852 ()
89185

  • Dental abrasive point, single-use
Iowa State fixation forceps, 3 3/8'', straight shafts, 1x2 teeth, flat 3-hole handle
AMBLER SURGICAL CORP.
Iowa State fixation forceps
In Commercial Distribution

  • 00190660204341 ()
9503E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit.
Care Innovations, LLC
Mobile RPM - Enterprise
Not in Commercial Distribution

  • 00850040853025 ()


  • Vulnerable patient home-monitoring software, professional-only
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device.
Care Innovations, LLC
Mobile RPM - BYOD
Not in Commercial Distribution

  • 00850040853018 ()


  • Vulnerable patient home-monitoring software, professional-only
Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients. The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated. Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications.
Care Innovations, LLC
Maestro RPM
Not in Commercial Distribution

  • 00850040853001 ()


  • 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
1.2.11
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
1.2.10
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
1.2.9
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
1.2.8
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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