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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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FreeStyle Libre 2 Plus Sensor
ABBOTT DIABETES CARE INC
78747
In Commercial Distribution

  • 30357599835003 ()
  • 00357599835002 ()
  • 57599-0835-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 14 day Sensor Kit NFRS
ABBOTT DIABETES CARE INC
71939
In Commercial Distribution

  • 30357599001026 ()
  • 00357599001025 ()
  • 57599-0001-02 ()
71939

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 14 day Reader Kit US
ABBOTT DIABETES CARE INC
71937
In Commercial Distribution

  • 57599-0000-97 ()
  • 00357599000974 ()
  • 30357599000975 ()
71937

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Reader Kit US
ABBOTT DIABETES CARE INC
71701
Not in Commercial Distribution

  • 30357599000227 ()
  • 00357599000226 ()
  • 57599-0000-22 ()
71701

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Sensor Kit
ABBOTT DIABETES CARE INC
71702
Not in Commercial Distribution

  • 30357599000203 ()
  • 00357599000202 ()
  • 57599-0000-20 ()
71702

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
OneTouch Verio Flex Blood Glucose Monitoring System
LifeScan Europe GmbH
024-336
In Commercial Distribution

  • 20353885012793 ()
  • 00353885012799 ()
  • 53885-336-01 ()
024-336

  • Glucose monitoring system IVD, home-use
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-268
In Commercial Distribution

  • 20353885007713 ()
  • 00353885007719 ()
  • 53885-854-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
022-268

  • Glucose monitoring system IVD, home-use
  • Glucose IVD, control
  • Manual blood lancing device, reusable
  • Blood lancing device tip
  • Glucose IVD, kit, electrometry
FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
78754
In Commercial Distribution

  • 30357599842001 ()
  • 00357599842000 ()
  • 57599-0842-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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