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
APP PUMP NO PRESSURE REGULATOR
COMPASS HEALTH BRANDS CORP.
1001
In Commercial Distribution

  • 30815067040033 ()
  • 00815067040032 ()


  • Alternating-pressure inflator
MY MASSAGE APP CONTROLLED CUSH
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
MCS-1000HJ
In Commercial Distribution

  • 10031262071719 ()
  • 00031262071712 ()


  • Bed/chair electric massager
TRUE MANAGER AIR APP - Android
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Android
In Commercial Distribution

  • 00021292013622 ()


  • Self-care monitoring/reporting software
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
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
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