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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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Stork - 00843997009416

Stork Vitals
MASIMO CORPORATION
95083
In Commercial Distribution

  • 00843997017589 ()
  • 00843997009416 ()


  • Wearable multiple vital physiological parameter monitoring system

Radius VSM - 00843997016391

Radius VSM Kit with NIBP
MASIMO CORPORATION
9035
In Commercial Distribution

  • 00843997009263 ()
  • 00843997016391 ()


  • Wearable multiple vital physiological parameter monitoring system

Radius VSM - 00843997016384

Radius VSM Kit with Reusable Pod
MASIMO CORPORATION
9034
In Commercial Distribution

  • 00843997009263 ()
  • 00843997016384 ()


  • Wearable multiple vital physiological parameter monitoring system

Radius VSM - 00843997016377

Radius VSM Kit
MASIMO CORPORATION
9033
In Commercial Distribution

  • 00843997009263 ()
  • 00843997016377 ()


  • Wearable multiple vital physiological parameter monitoring system

Radius VSM - 00843997011549

Radius VSM Kit with Reusable Pod & NIBP
MASIMO CORPORATION
9036
In Commercial Distribution

  • 00843997010337 ()
  • 00843997011549 ()


  • Wearable multiple vital physiological parameter monitoring system

Stork - 00843997010238

Stork Sensor
MASIMO CORPORATION
95094
In Commercial Distribution

  • 00843997017589 ()
  • 00843997010238 ()


  • Wearable multiple vital physiological parameter monitoring system

Radius VSM - 00843997009065

Radius VSM Multi-functional Reusable Pod, 1/Box
MASIMO CORPORATION
4888
In Commercial Distribution

  • 00843997009065 ()


  • Wearable multiple vital physiological parameter monitoring system

Stork - 00843997007689

Stork Vitals+
MASIMO CORPORATION
95082
In Commercial Distribution

  • 00843997017589 ()
  • 00843997007689 ()


  • Wearable multiple vital physiological parameter monitoring system

Masimo W1 - 00843997005364

Masimo W1, Tele-Health, Global
MASIMO CORPORATION
95080
In Commercial Distribution

  • 00843997005364 ()


  • Wearable multiple vital physiological parameter monitoring system

FUKUDA DENSHI - 04538612915895

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812R
In Commercial Distribution

  • 04538612915895 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915888

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800LR
In Commercial Distribution

  • 04538612915888 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915857

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812RE
In Commercial Distribution

  • 04538612915857 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915840

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812
In Commercial Distribution

  • 04538612915840 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915833

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800LRE
In Commercial Distribution

  • 04538612915833 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915826

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800L
In Commercial Distribution

  • 04538612915826 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612912061

No Description
FUKUDA DENSHI CO.,LTD.
LC-8026T
In Commercial Distribution

  • 04538612912061 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612912047

No Description
FUKUDA DENSHI CO.,LTD.
DS-8900
In Commercial Distribution

  • 04538612912047 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612911071

No Description
FUKUDA DENSHI CO.,LTD.
LW-7080(G)
In Commercial Distribution

  • 04538612911071 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908354

No Description
FUKUDA DENSHI CO.,LTD.
DS-7780W
In Commercial Distribution

  • 04538612908354 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908330

No Description
FUKUDA DENSHI CO.,LTD.
DS-7700WL
In Commercial Distribution

  • 04538612908330 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908316

No Description
FUKUDA DENSHI CO.,LTD.
DS-7780
In Commercial Distribution

  • 04538612908316 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908293

No Description
FUKUDA DENSHI CO.,LTD.
DS-7700L
In Commercial Distribution

  • 04538612908293 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908279

No Description
FUKUDA DENSHI CO.,LTD.
LW-7080
In Commercial Distribution

  • 04538612908279 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612908248

No Description
FUKUDA DENSHI CO.,LTD.
LC-7019FT
In Commercial Distribution

  • 04538612908248 ()


  • Centralized patient monitor

Hepatogram Plus - 00850011790199

No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software

MREplus - 00850011790014

No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software

MREplus - 00850011790007

No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software

Vave - 00850001977043

Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software

suiteHEART - 00850001088015

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software

suiteHEART - 00850001088008

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution

  • 00850001088008 ()


  • MRI system application software
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