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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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PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
HEMPC2K
In Commercial Distribution

  • 00690103217124 ()
HEMPC2K

  • General-purpose multi-parameter bedside monitor
HemoSphere Tissue Oximetry Module
Edwards Lifesciences LLC
HEMTOM10
In Commercial Distribution

  • 00690103200355 ()
HEMTOM10

  • General-purpose multi-parameter bedside monitor
Vita Technology Module
Edwards Lifesciences LLC
HEMVTOM1
In Commercial Distribution

  • 00690103218862 ()
HEMVTOM1

  • General-purpose multi-parameter bedside monitor
VitaWave Module
Edwards Lifesciences LLC
HEMVWM1
In Commercial Distribution

  • 00690103218848 ()
HEMVWM1

  • General-purpose multi-parameter bedside monitor
FORESIGHT OXIMETER CABLE
Edwards Lifesciences LLC
HEMFSM10
In Commercial Distribution

  • 00690103210927 ()
HEMFSM10

  • General-purpose multi-parameter bedside monitor
HEMOSPHERE FORESIGHT MODULE
Edwards Lifesciences LLC
HEMFSM10
In Commercial Distribution

  • 00690103208573 ()

  • Monitor: Height: 297 mm, Width: 315 mm, Depth: 141 mm, Weight: 4.5 kg (10 lbs)
HEMFSM10

  • Tissue saturation oximeter
  • General-purpose multi-parameter bedside monitor
CLEARSIGHT MODULE
Edwards Lifesciences LLC
HEMCSM10
In Commercial Distribution

  • 00690103202762 ()
HEMCSM10

  • General-purpose multi-parameter bedside monitor
Pressure Cable
Edwards Lifesciences LLC
HEMPSC100
In Commercial Distribution

  • 00690103199321 ()

  • Pressure Cable: Length: 3 m (10 ft) and 4.6 m (15 ft)
HEMPSC100

  • General-purpose multi-parameter bedside monitor
The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is also intended for the collection and recording of basic vital signs on adult and pediatric patients, excluding neonates.
Schiller AG
3.930535
In Commercial Distribution

  • 07613365000498 ()
3.930535

  • Electrocardiograph, professional, multichannel
The Diagnostic Station DS20 is a 3-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is also intended for the collection and recording of basic vital signs on adult and pediatric patients, excluding neonates.
Schiller AG
3.930525
In Commercial Distribution

  • 07613365000481 ()
3.930525

  • Electrocardiograph, professional, multichannel
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