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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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Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.1
Biim Ultrasound AS
P001117
In Commercial Distribution

  • 07090045490013 ()
P001117

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
Water-based Personal Lubricant
CC Wellness LLC
41022
In Commercial Distribution

  • B362410220 ()
  • 00851271008048 ()
  • 00851271008031 ()


  • Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
70127
In Commercial Distribution

  • B362701271 ()
  • B362701270 ()


  • Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
70125
In Commercial Distribution

  • B362701251 ()
  • B362701250 ()


  • Sexual lubricant
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