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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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TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Unitron Remote Plus 5.0 app
Sonova AG
088-5016
In Commercial Distribution

  • 07613389610918 ()
088-5016

  • Audiometric/hearing device software
APP PUMP NO PRESSURE REGULATOR
COMPASS HEALTH BRANDS CORP.
1001
In Commercial Distribution

  • 30815067040033 ()
  • 00815067040032 ()


  • Alternating-pressure inflator
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution

  • 00606959057678 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
DreamMapper Mobile App Android EMEA, - 2
In Commercial Distribution

  • 00606959057661 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android (DMM)
Respironics, Inc.
DreamMapper Mobile App Android, North America Instance - 2
In Commercial Distribution

  • 00606959057654 ()
1101479

  • Self-care monitoring/reporting software
G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
Not in Commercial Distribution

  • 03770014642226 ()


  • Pelvic floor muscle exerciser
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser
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