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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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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

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

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

Visix - 00851800007092

Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software

LATITUDE Consult™ - 00802526562907

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562907 ()


  • Cardiac pulse generator software

LATITUDE Consult™ - 00802526562914

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562914 ()


  • Cardiac pulse generator software

Vision RT - B120ALIGNRT0

No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system
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