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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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cobas Liat Influenza A/B Script Version 1.32 - 07613336150047

No Description
Roche Molecular Systems, Inc.
08302375001
Not in Commercial Distribution

  • 07613336150047 ()
08302375001

  • Laboratory instrument/analyser application software IVD

cobas® Liat® Strep A Script - 07613336129692

No Description
Roche Molecular Systems, Inc.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD

cobas® Liat® Influenza A/B Script - 07613336129685

No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD

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

Omnipod 5 Pod - 10385083000527

Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution

  • 20385083000531 ()
  • 10385083000527 ()
  • 20385083000579 ()
  • 20385083000753 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Starter Kit - 10385083000503

Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

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

Omnipod 5 Controller - 10385083000022

Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution

  • 10385083000022 ()
  • 30385083000019 ()
  • 30385083000095 ()
SKT-H001-G-X9

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Pod - 10385083000114

Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution

  • 10385083000213 ()
  • 10385083000114 ()
  • 10385083000138 ()
  • 20385083000210 ()
  • 20385083000135 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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