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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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RhythmView - 00810591020161

RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system

RhythmView - 00810591020154

USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system

RhythmView - 00810591020130

RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system

RhythmView - 00810591020116

RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system

RhythmView - 00810591020109

Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system

medilog DARWIN2 U - 07613365003758

The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Schiller AG
0.282200
In Commercial Distribution

  • 07613365003758 ()
0.282200

  • Electrocardiographic long-term ambulatory recording analyser application software

Premier Heart MCG Model VH12 - B320VH120

Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel

Premier Heart MCG Analysis API - B320MCGS0

MCG Analysis API (Dedicated Server or Software-as-a-Service)
PREMIER HEART, LLC
MCGS
In Commercial Distribution

  • B320MCGS0 ()


  • Cardiopulmonary physiological parameter analysis software

Premier Heart MCG Analysis Software - B320MCGC0

Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution

  • B320MCGC0 ()


  • Cardiopulmonary physiological parameter analysis software

Premier Heart MCG - B320CF190

Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel
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