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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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EV1000 - 00690103190144

EV1000 FLOTRAC CABLE
Edwards Lifesciences LLC
EVFTC1
In Commercial Distribution

  • 00690103190144 ()

  • Length: 192 Inch
EVFTC1

  • Electrical-only medical device connection cable, reusable

EV1000 - 00690103190137

EV1000 ETHERNET CABLE
Edwards Lifesciences LLC
EVEC1
In Commercial Distribution

  • 00690103190137 ()

  • Length: 6 Feet
EVEC1

  • Electrical-only medical device connection cable, reusable

EV1000 - 00690103190113

EV1000 DATABOX ASSEMBLY
Edwards Lifesciences LLC
EV1000DB
In Commercial Distribution

  • 00690103190113 ()

  • Height: 145 mm, Width: 206 mm, Depth: 64 mm, Weight: 0.9 kg (2.0 lbs)
EV1000DB

  • General-purpose multi-parameter bedside monitor

EV1000 - 00690103190106

EV1000 MONITOR
Edwards Lifesciences LLC
EV1000M
In Commercial Distribution

  • 00690103190106 ()

  • HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS)
EV1000M

  • Patient monitoring system module, blood pressure, noninvasive
  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor

EV1000 - 00690103189650

EV1000 PLATFORM
Edwards Lifesciences LLC
EV1000A
In Commercial Distribution

  • 00690103189650 ()

  • MONITOR: HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS), DATABOX: HEIGHT: 145 MM, WIDTH: 206 MM, DEPTH: 64 MM, WEIGHT: 0.9 KG (2.0 LBS)
EV1000A

  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor

CorVista® System with CAD Add-On - 00869059000436

CorVista System with CAD Add-On
Analytics for Life Inc.
CorVista System with CAD Add-On
In Commercial Distribution

  • 00869059000436 ()


  • Multiparameter physiologic analysis workstation

CorVista® System - 00869059000429

CorVista® System with CAD Add-On
Analytics for Life Inc.
10-0020
In Commercial Distribution

  • 00869059000429 ()


  • Multiparameter physiologic analysis workstation

MediPines Gas Exchange Monitor Starter Kit - 00860001261530

Breathing Circuit and Nose Clip, Single Use, 10 pieces each
MEDIPINES CORPORATION
MPSK10
In Commercial Distribution

  • 00860001261530 ()
  • 00860001261554 ()
MPSK10

  • Nose clip, single-use
  • Breathing mouthpiece, single-use

MediPines Single Patient Use Breathing Circuit - 00860001261516

Breathing Circuit Kit, Single Patient Use, 10
MEDIPINES CORPORATION
AGM316
In Commercial Distribution

  • 00860001261516 ()
  • 00860001261523 ()
  • 00860001261547 ()
  • 00860001261561 ()
AGM316-10, AGM316-50, AGM316-100

  • Breathing mouthpiece, single-use

RHYTHMIA HDx™ - 08714729948377

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14510
In Commercial Distribution

  • 08714729948377 ()


  • Cardiac mapping system
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