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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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Sensis - 04056869010137

No Description
Siemens Healthcare GmbH
10764561
In Commercial Distribution

  • 04056869010137 ()


  • Cardiac catheterization laboratory computer

Merge Hemo Link Assembly - 00842000100515

Merge Hemo 77-00327-00 Link Assembly
MERGE HEALTHCARE SOLUTIONS INC.
77-00327-00
In Commercial Distribution

  • 00842000100515 ()


  • Cardiac catheterization laboratory computer

Merge HEMO - 00842000100034

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100034 ()


  • Cardiac catheterization laboratory computer

Merge Hemo - 00842000100010

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.0.4
In Commercial Distribution

  • 00842000100010 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Console with dPR - 10841716103763

RXi Console with dPR, US (p/n: 800939-010 )
ACIST MEDICAL SYSTEMS, INC.
019994
In Commercial Distribution

  • 10841716103763 ()
  • 30841716103767 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Navvus Interface - 10841716101790

RXi Mini Navvus Interface p/n 701600-002
ACIST MEDICAL SYSTEMS, INC.
018592
In Commercial Distribution

  • 30841716101794 ()
  • 10841716101790 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Processing Unit - 10841716101783

RXi Mini Processing Unit p/n 701630-002
ACIST MEDICAL SYSTEMS, INC.
018593
In Commercial Distribution

  • 30841716101787 ()
  • 10841716101783 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Mount - 10841716101769

RXi Mini Mounts p/n 701601-008
ACIST MEDICAL SYSTEMS, INC.
018594
In Commercial Distribution

  • 30841716101763 ()
  • 10841716101769 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System - 10841716101738

RXi System Console, p/n 701640-001
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 30841716101732 ()
  • 10841716101738 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Ao Interface Box - 10841716101448

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

ACIST RXi® System - 10841716101257

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

  • 30841716100384 ()
  • 10841716101257 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Cart - 10841716100595

RXi Cart, p/n 701606-001
ACIST MEDICAL SYSTEMS, INC.
018111
In Commercial Distribution

  • 30841716100599 ()
  • 10841716100595 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Bed Rail Mount - 10841716100588

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

  • 10841716100588 ()
  • 30841716100582 ()


  • Cardiac catheterization laboratory computer

KEYBOARD - 04953170264955

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1710
Not in Commercial Distribution

  • 04953170264955 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170356087

MAJ-1710 EU-ME1 Keyboard
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1710
Not in Commercial Distribution

  • 04953170356087 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170343384

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1995
In Commercial Distribution

  • 04953170343384 ()
N4505930

  • Computer/medical device keyboard

KEYBOARD - 04953170338540

MAJ-1981 KEYBOARD FOR CV-170
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1981
In Commercial Distribution

  • 04953170338540 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170304927

MAJ-1921 VISERA ELITE KEYBOARD
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1921
In Commercial Distribution

  • 04953170304927 ()
N3646630

  • Computer/medical device keyboard

KEYBOARD - 04953170356797

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1995
In Commercial Distribution

  • 04953170356797 ()
N4505940

  • Computer/medical device keyboard

PENTAX Medical - 04961333251650

PENTAX Medical Keyboard EN OS-A116
HOYA CORPORATION
OS-A116
In Commercial Distribution

  • 04961333251650 ()


  • Computer/medical device keyboard

PENTAX Medical - 04961333247462

PENTAX Medical Keyboard EN OS-A115
HOYA CORPORATION
OS-A115
In Commercial Distribution

  • 04961333247462 ()


  • Computer/medical device keyboard

PENTAX Medical - 04961333233557

PENTAX Medical Keyboard EN OS-A111
HOYA CORPORATION
OS-A111
In Commercial Distribution

  • 04961333233557 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170222542

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1463
In Commercial Distribution

  • 04953170222542 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170214493

MAJ-1428 KEYBOARD EVIS EXERA II
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1428
In Commercial Distribution

  • 04953170214493 ()


  • Computer/medical device keyboard

VISERA VIDEO SYSTEM CENTER - 04953170142055

MAJ-1124 VISERA SYSTEM KEYBOARD
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1124
In Commercial Distribution

  • 04953170142055 ()


  • Computer/medical device keyboard

KEY BOARD - 04953170026324

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-844
In Commercial Distribution

  • 04953170026324 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410388992

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard

Gyrus ACMI - 00821925018075

COTTLE SKIN HOOK LONG EBONY FINISH
Gyrus ACMI, LLC
270210
Not in Commercial Distribution

  • 00821925018075 ()


  • Cardiac mapping system computer

GEMS Win HL7 - 00812324000266

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 - 00812324000259

GEMS Win Air
CardioComm Solutions, Inc
GW-AIR
In Commercial Distribution

  • 00812324000259 ()
GW-AIR

  • Cardiac mapping system computer

GEMS Win AutoAttendant - 00812324000242

GEMS Win AutoAttendant
CardioComm Solutions, Inc
GW-AA
In Commercial Distribution

  • 00812324000242 ()
GW-AA

  • Cardiac mapping system computer

GEMS Win TTM & ICD - 00812324000228

GEMS Win ARR TTM & Full Pacing
CardioComm Solutions, Inc
GW-TTMICD
In Commercial Distribution

  • 00812324000228 ()
GW-TTMICD

  • Cardiac mapping system computer

GEMS Win TTM - 00812324000211

Global ECG Management System for Windows with Arrhythmia and TTM
CardioComm Solutions, Inc
GW-TTM
In Commercial Distribution

  • 00812324000211 ()
GW-TTM

  • Cardiac mapping system computer

GEMS Win Arrhythmia - 00812324000204

Global ECG Management System (GEMS) for Windows Arrhythmia
CardioComm Solutions, Inc
GW-ARR
In Commercial Distribution

  • 00812324000204 ()
GW-ARR

  • Cardiac mapping system computer

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

McKesson Cardiology Hemo - 80010939050027

No Description
Change Healthcare Canada Company
14.0
In Commercial Distribution

  • 80010939050027 ()


  • Cardiac catheterization laboratory computer

McKesson Cardiology Hemo - 80010939050010

No Description
Change Healthcare Canada Company
13.2.1
In Commercial Distribution

  • 80010939050010 ()


  • Cardiac catheterization laboratory computer

McKesson Cardiology ECG Management - 80010939040028

No Description
Change Healthcare Canada Company
14.0
In Commercial Distribution

  • 80010939040028 ()


  • Cardiac mapping system computer
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