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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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SmartScreener-Plus2 Screener Launch - 00817020020822

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M812002
In Commercial Distribution

  • 00817020020822 ()


  • Bioelectrical signal analysis software

AED Manager, V.2.2.1.1 Powerheart G5 - 00812394021505

Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution

  • 00812394021505 ()
40-00296-05

  • External defibrillator application software

Powerheart® MDLink - 00812394021499

MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software

Powerheart® MDLink - 00812394021321

MDLink SW 10.16
Zoll Medical Corporation
400621-046
In Commercial Distribution

400621-046

  • External defibrillator application software

AED Manager, V.2.1.1.0 Powerheart G5 - 00812394021314

Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5
Zoll Medical Corporation
XAEDMGR01E
In Commercial Distribution

XAEDMGR01E

  • External defibrillator application software

AED Manager, V.2.0.5.0 Powerheart G5 - 00812394020539

Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution

  • 00812394020539 ()
XAEDMGR01C

  • External defibrillator application software

Powerheart® MDLink - 00812394020393

MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution

  • 00812394020393 ()
400621-045

  • External defibrillator application software

AED Manager, Powerheart G5 - 00812394020188

Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution

  • 00812394020188 ()
XAEDMGR01D

  • External defibrillator application software

Floodlight MS U-Turn Test - 07613336193341

No Description
Roche Molecular Systems, Inc.
09342311001
In Commercial Distribution

  • 07613336193341 ()
09342311001

  • Self-care monitoring/reporting software

Floodlight MS U-Turn Test - 07613336193334

No Description
Roche Molecular Systems, Inc.
09342290001
In Commercial Distribution

  • 07613336193334 ()
09342290001

  • Self-care monitoring/reporting software
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