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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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Ao Interface Box, p/n 701587-001 Contents: Ao interface box, mounting bracket, cables
ACIST MEDICAL SYSTEMS, INC.
018311
In Commercial Distribution

  • 30841716101442 ()
  • 10841716101448 ()


  • Cardiac catheterization laboratory computer
RXi System Console, p/n 701309-008
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 30841716100384 ()
  • 10841716101257 ()


  • Cardiac catheterization laboratory computer
RXi Cart, p/n 701606-001
ACIST MEDICAL SYSTEMS, INC.
018111
In Commercial Distribution

  • 30841716100599 ()
  • 10841716100595 ()


  • Cardiac catheterization laboratory computer
RXi Bed Rail Mount, p/n 701605-001
ACIST MEDICAL SYSTEMS, INC.
017753
In Commercial Distribution

  • 10841716100588 ()
  • 30841716100582 ()


  • Cardiac catheterization laboratory computer
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • Cardiac mapping system computer
HL7 plug-in module for GEMS Win
CardioComm Solutions, Inc
GW-HL7
In Commercial Distribution

  • 00812324000266 ()
GW-HL7

  • Cardiac mapping system computer
GEMS Win Air
CardioComm Solutions, Inc
GW-AIR
In Commercial Distribution

  • 00812324000259 ()
GW-AIR

  • Cardiac mapping system computer
GEMS Win AutoAttendant
CardioComm Solutions, Inc
GW-AA
In Commercial Distribution

  • 00812324000242 ()
GW-AA

  • Cardiac mapping system computer
GEMS Win ARR TTM & Full Pacing
CardioComm Solutions, Inc
GW-TTMICD
In Commercial Distribution

  • 00812324000228 ()
GW-TTMICD

  • Cardiac mapping system computer
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