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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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OptoMonitor 3 - 07540184320127

No Description
Opsens Inc
OpM3-DU Power Supply Cable
In Commercial Distribution

  • 07540184320127 ()
F232012

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184320110

No Description
Opsens Inc
OpM3-OU Power Supply Cable
In Commercial Distribution

  • 07540184320110 ()
F232011

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184320103

No Description
Opsens Inc
OpM3 OU-DU LAN Cable
In Commercial Distribution

  • 07540184320103 ()
F232010

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184320097

No Description
Opsens Inc
OpM3 OU-DU RS-232 comm cable
In Commercial Distribution

  • 07540184320097 ()
F232009

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184040032

No Description
Opsens Inc
Reference probe 18500nm
In Commercial Distribution

  • 07540184040032 ()
F204003

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184040025

No Description
Opsens Inc
Reference probe 14800nm
In Commercial Distribution

  • 07540184040025 ()
F204002

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184040018

No Description
Opsens Inc
Reference probe 16500nm
In Commercial Distribution

  • 07540184040018 ()
F204001

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184023301

No Description
Opsens Inc
OpM3 Handle Unit
In Commercial Distribution

  • 07540184023301 ()
F2330

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184023226

No Description
Opsens Inc
OpM3-DU Wireless dongle
In Commercial Distribution

  • 07540184023226 ()
F2322

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184023219

No Description
Opsens Inc
OpM3 Display Unit 15"
In Commercial Distribution

  • 07540184023219 ()
F2321

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184023202

No Description
Opsens Inc
OpM3 Display Unit 10"
In Commercial Distribution

  • 07540184023202 ()
F2320

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184023103

No Description
Opsens Inc
OpM3 Optical Unit
In Commercial Distribution

  • 07540184023103 ()
F2310

  • Cardiac catheterization laboratory computer

OptoMonitor - 07540184020300

No Description
Opsens Inc
Handle Unit
In Commercial Distribution

  • 07540184020300 ()
F2030

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013197

No Description
Opsens Inc
AO cable - METEK David
In Commercial Distribution

  • 07540184013197 ()
F201319

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013180

No Description
Opsens Inc
AO cable - Siemens Sensis 7pins
In Commercial Distribution

  • 07540184013180 ()
F201318

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013173

No Description
Opsens Inc
AO cable - Fysicon QMAPP
In Commercial Distribution

  • 07540184013173 ()
F201317

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013166

No Description
Opsens Inc
AO cable - Schwarzer Cardis 5000
In Commercial Distribution

  • 07540184013166 ()
F201316

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013159

No Description
Opsens Inc
AO cable - Claris WorkMate
In Commercial Distribution

  • 07540184013159 ()
F201315

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013142

No Description
Opsens Inc
AO cable - Ortivus Coronet
In Commercial Distribution

  • 07540184013142 ()
F201314

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013135

No Description
Opsens Inc
AO cable - Siemens Recor
In Commercial Distribution

  • 07540184013135 ()
F201313

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013128

No Description
Opsens Inc
AO cable - Mckesson/Merge
In Commercial Distribution

  • 07540184013128 ()
F201312

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013111

No Description
Opsens Inc
AO cable - QynetiQ
In Commercial Distribution

  • 07540184013111 ()
F201311

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013104

No Description
Opsens Inc
AO cable - BARD Clearsign
In Commercial Distribution

  • 07540184013104 ()
F201310

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013098

No Description
Opsens Inc
AO cable - Mennen Model 267
In Commercial Distribution

  • 07540184013098 ()
F201309

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013067

No Description
Opsens Inc
AO cable - Nihon Koden
In Commercial Distribution

  • 07540184013067 ()
F201306

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013043

No Description
Opsens Inc
AO cable - Philips Xper Flex Cardio 2.9m
In Commercial Distribution

  • 07540184013043 ()
F201304

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184013029

No Description
Opsens Inc
AO cable - GE TRAM 2.9m
In Commercial Distribution

  • 07540184013029 ()
F201302

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012206

No Description
Opsens Inc
Pressure output cable - METEK David
In Commercial Distribution

  • 07540184012206 ()
F201220

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012121

No Description
Opsens Inc
Pressure output cable - Mckesson/Merge
In Commercial Distribution

  • 07540184012121 ()
F201212

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012114

No Description
Opsens Inc
Pressure output cable - QynetiQ
In Commercial Distribution

  • 07540184012114 ()
F201211

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012091

No Description
Opsens Inc
Pressure output cable - Mennen Model 267
In Commercial Distribution

  • 07540184012091 ()
F201209

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012060

No Description
Opsens Inc
Pressure output cable - Nihon Koden
In Commercial Distribution

  • 07540184012060 ()
F201206

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012046

No Description
Opsens Inc
Pressure output cable - Philips XPER
In Commercial Distribution

  • 07540184012046 ()
F201204

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012039

No Description
Opsens Inc
Pressure output cable - Siemens Sensis
In Commercial Distribution

  • 07540184012039 ()
F201203

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012022

No Description
Opsens Inc
Pressure output cable - GE TRAM
In Commercial Distribution

  • 07540184012022 ()
F201202

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184012015

No Description
Opsens Inc
Pressure output cable - Philips/WITT
In Commercial Distribution

  • 07540184012015 ()
F201201

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184011179

No Description
Opsens Inc
AUX interface cable - Fysicon QMAPP
In Commercial Distribution

  • 07540184011179 ()
F201117

  • Cardiac catheterization laboratory computer

OptoMonitor 3 - 07540184010042

No Description
Opsens Inc
AC Power cord C13 to P5 15P HG NA
In Commercial Distribution

  • 07540184010042 ()
F201004

  • Cardiac catheterization laboratory computer

ACIST RXi® System with dPR - 40841716103757

RXi System with dPR, US (p/n: 800981-010 )
ACIST MEDICAL SYSTEMS, INC.
019995
In Commercial Distribution

  • 40841716103757 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini System Overpack - 40841716101753

RXi Mini System, p/n 801042-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Power Cord and Cables)
ACIST MEDICAL SYSTEMS, INC.
018599
In Commercial Distribution

  • 40841716101753 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System and Accessories - 40841716101746

RXi System Overpack, p/n 800981-004 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 40841716101746 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini System Overpack - 40841716101586

RXi Mini System, p/n 801075-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Power Cord and Cables)
ACIST MEDICAL SYSTEMS, INC.
018599
In Commercial Distribution

  • 40841716101586 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System and Accessories - 40841716100763

RXi System Overpack, p/n 801005-002 Contents: Refurbished Console, Power Supply, Bed Mount, USB Drive
ACIST MEDICAL SYSTEMS, INC.
018083
Not in Commercial Distribution

  • 40841716100763 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System and Accessories - 40841716100732

RXi System Overpack, p/n 801027-001 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 40841716100732 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Console, Refurbished - 40841716100688

RXi System Console Refurbished, p/n 801004-001 Contents: Refurbished Console, Power Supply, and USB Drive
ACIST MEDICAL SYSTEMS, INC.
018084
Not in Commercial Distribution

  • 40841716100688 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System and Accessories - 40841716100671

RXi System Overpack, p/n 800981-003 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 40841716100671 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® System and Accessories - 40841716100664

RXi System Overpack, p/n 800981-002 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
ACIST MEDICAL SYSTEMS, INC.
014666
Not in Commercial Distribution

  • 40841716100664 ()


  • Cardiac catheterization laboratory 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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