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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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LF - 10746190004806

OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary

LF - 10746190004813

OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary

AirStrip OB Legacy iOS - B15310010

OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter

AirStrip OB Legacy Server - B15310000

OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter

Cardiostation Premier Stand Alone Software - B147CSS0

Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system

Cardiostation® Advantage Software - B147CA0

Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system

UNITRON - 07613389221589

TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software

UNITRON - 07613389221572

TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software

HANSATON - 07613389143232

USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software

HANSATON - 07613389143225

DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software
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