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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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Epiphany Cardio Server - 00860991000348

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.0
In Commercial Distribution

  • 00860991000348 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000331

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.4
In Commercial Distribution

  • 00860991000331 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000324

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.3
In Commercial Distribution

  • 00860991000324 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000317

ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.2.0
In Commercial Distribution

  • 00860991000317 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000300

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.1.0
In Commercial Distribution

  • 00860991000300 ()


  • Cardiology information system application software

eRAD RIS - 00866994000248

eRAD RIS v3.2018
Erad, Inc.
3.18
In Commercial Distribution

  • 00866994000248 ()


  • Radiology information system application software

eRAD RIS - 00866994000231

eRAD RIS v2.2016
Erad, Inc.
2.16
In Commercial Distribution

  • 00866994000231 ()


  • Radiology information system application software

EnsoSleep PPG - 00864458000469

Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000469 ()


  • Sleep disorder interpretive software, professional-only

Celeste+ - 00864458000452

Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000452 ()


  • Sleep disorder interpretive software, professional-only

EnsoSleep PPG - 00864458000445

Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
ENSODATA, INC.
7.0
Not in Commercial Distribution

  • 00864458000445 ()


  • Sleep disorder interpretive software, professional-only
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