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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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Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Monarch™ Cart Software v4.1.1 - 10810068811503

Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.1 - 10810068811497

Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software

Vital Sync - 10884521851559

VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521815810

Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Puritan Bennett - 10884521211551

IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

Paradigm - 00850042604014

Paradigm System Cart, 120-volt
Proprio, Inc.
1100006
In Commercial Distribution

  • 00850042604014 ()
1100006

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Paradigm - 00850042604007

Paradigm System Cart
Proprio, Inc.
1100001
Not in Commercial Distribution

  • 00850042604007 ()
  • 10850042604004 ()
1100003

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Stealth System S300 - 00857553006092

StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution

  • 00857553006092 ()
  • 00857553006061 ()
C300/D300

  • Electrocardiographic ambulatory recorder
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