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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Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
APP (Pads only)
COMPASS HEALTH BRANDS CORP.
SA901P
Not in Commercial Distribution

  • 00841447104070 ()
SA901P

  • Air-filled bed mattress overlay
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software
Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
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