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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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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 - 05060526847706

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

  • 05060526847706 ()
WD-A-001

  • General-purpose multi-parameter bedside monitor

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

Portrait CSSXB - 00195278659446

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software

Portrait CVAXB - 00195278656681

Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

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

PORTRAIT SBT01 - 00195278120014

SENSOR BATTERY DEVICE ASSEMBLY
GE Healthcare Finland Oy
SBT01
In Commercial Distribution

  • 00195278366085 ()
  • 00195278120014 ()
2096442-001

  • Multiple vital physiological parameter monitoring system transceiver

PORTRAIT MMP01 - 00195278110435

Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
GE Healthcare Finland Oy
MMP01
In Commercial Distribution

  • 00195278110435 ()
5514246

  • Personal device holder, single-use

PORTRAIT BCH01 - 00195278094001

CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
BCH01
In Commercial Distribution

  • 00195278094001 ()
2096439-001

  • Noninvasive device battery charger

PORTRAIT HUB01 - 00195278093998

HUB, AMBULATORY HUB DEVICE ASSEMBLY
GE Healthcare Finland Oy
HUB01
In Commercial Distribution

  • 00195278093998 ()
2096437-001

  • Wearable multiple vital physiological parameter monitor
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