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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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SWR KIT SSPRO SOFTWARE VER 11
VYAIRE MEDICAL, INC.
28008-001
In Commercial Distribution

  • 10190752161993 ()
28008-001

  • Home-use sleep apnoea recording system
Sleepware G3 Software Package, Multi Lingual
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004856 ()
1082463

  • Polysomnography analyser
HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
Somte Recording System Compumedics, no Software
COMPUMEDICS LIMITED
Somte
In Commercial Distribution

  • 09342451001733 ()
9012-0003-01

  • Polysomnograph
Somte PSG v2 System, No software
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001368 ()
9023-0002-01

  • Polysomnograph
Grael EEG v2 System - no software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001252 ()
9028-0003-02

  • Electroencephalograph
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software
Applied Speech Science for Dysarthrias, Software
PENTAX OF AMERICA, INC.
5153
Not in Commercial Distribution

  • 04961333229840 ()


  • Electroglottograph
Respiration, Phonation and Prosody Simulation, Software
PENTAX OF AMERICA, INC.
5152
Not in Commercial Distribution

  • 04961333229833 ()


  • Electroglottograph
Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software
Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable
Knee Software Package, ART 2.3 Add-on
Omni Life Science, Inc.
NS-27010
In Commercial Distribution

  • 00841690194507 ()
NS-27010

  • Instrument tray, reusable
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software
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