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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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Alinity c ACE Assay File - 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD

ARCHITECT c ACE Assay File - 08058056685438

The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • 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 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 - 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 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

cobas Liat Strep A Script Version 1.27 - 07613336156544

No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution

  • 07613336156544 ()
08403856001

  • Laboratory instrument/analyser application software IVD
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