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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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Sonova - 07613389310962

Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software

Omnipod 5 Controller APP - 10385083000565

Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Meridian Medical - 00815067042562

BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable

Meridian Medical - 00815067040162

APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system

All-Day Clear 1.0 app - 07613389557930

All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software

Unitron Brand - 07613389610925

Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software

PRC-Saltillo - 00816486021367

TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer

Biim Android App, P2.0 - 07090045490334

Biim Android App, P2.0
Biim Ultrasound AS
P001425
In Commercial Distribution

  • 07090045490334 ()
P001425

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held

Biim iOS App, P2.0 - 07090045490327

Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held

Biim Android App, P1.3.2 - 07090045490310

Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.3.2 - 07090045490303

Biim iOS App, P1.3.2
Biim Ultrasound AS
P001417
In Commercial Distribution

  • 07090045490303 ()
P001417

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.3.1 - 07090045490235

Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.3.1 - 07090045490228

Biim iOS App, P1.3.1
Biim Ultrasound AS
P001402
In Commercial Distribution

  • 07090045490228 ()
P001402

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.3 - 07090045490198

Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.3 - 07090045490181

Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.2 - 07090045490150

Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.2 - 07090045490143

Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.1 - 07090045490020

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 - 07090045490013

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 - 10385083000336

Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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