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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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Stethee Pro Mobile Android Application - 09351356000031

Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software

Spire Health Remote Patient Monitoring System - 00860008932204

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution

  • 00860008932204 ()


  • Wearable multiple vital physiological parameter monitoring system

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software

Current Health Wearable Monnitoring System - 05060526840004

Current Health Wearable Monnitoring System (Gen 1 Wearable)
CURRENT HEALTH LIMITED
G1
In Commercial Distribution

  • 05060526840004 ()
40

  • General-purpose multi-parameter bedside monitor

Current Health Wearable Monnitoring System - 05060526847706

Current Health Wearable Monitoring System
CURRENT HEALTH LIMITED
G2
In Commercial Distribution

  • 05060526847706 ()
WD-A-001

  • General-purpose multi-parameter bedside monitor

Portrait CSS01 - 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software

Portrait CVA01 - 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only

PORTRAIT SpO2 P-SA01 - 00195278264831

PORTRAIT SpO2 P-SA FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SA01
In Commercial Distribution

  • 00195278264831 ()
2103502-001

  • Pulse oximeter probe/processor

PORTRAIT SpO2 P-SE01 - 00195278264824

PORTRAIT SpO2 P-SE FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SE01
In Commercial Distribution

  • 00195278264824 ()
2104044-001

  • Pulse oximeter probe/processor

PORTRAIT RR P-RR01 - 00195278264817

PORTRAIT RR P-RR FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-RR01
In Commercial Distribution

  • 00195278264817 ()
2103567-001

  • Respiration rate signal processor/transmitter
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