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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 - 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

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

RHYTHMIA HDx™ - 08714729948360

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14010
In Commercial Distribution

  • 08714729948360 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948322

Breakout Box
BOSTON SCIENTIFIC CORPORATION
M004RH11020
In Commercial Distribution

  • 08714729948322 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729938668

Stimulator Jumper Cable
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS220
In Commercial Distribution

  • 08714729938668 ()
M004RAMMTIPS220

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938651

Patch Cable
BOSTON SCIENTIFIC CORPORATION
M004RALRCBL20
In Commercial Distribution

  • 08714729938651 ()


  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938620

CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG60
In Commercial Distribution

  • 08714729938620 ()


  • Electrocardiographic lead set, reusable
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