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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Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908964 ()
  • 08809115908957 ()
  • 8522-0000-64 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908452 ()
  • 8522-0000-22 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908438 ()
  • 8522-0000-23 ()
  • 08809115908445 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
G6 Receiver Kit (Retail)
Dexcom, Inc.
STK-OE-001
In Commercial Distribution

  • 00386270001900 ()
  • 08627-0091-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
FreeStyle Libre 2 Plus Sensor Not For Retail Sale
ABBOTT DIABETES CARE INC
78749
In Commercial Distribution

  • 30357599836000 ()
  • 00357599836009 ()
  • 57599-0836-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
72079
In Commercial Distribution

  • 57599-0820-00 ()
  • 00357599820008 ()
72079

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Sensor Kit NFRS
ABBOTT DIABETES CARE INC
72080
In Commercial Distribution

  • 30357599819003 ()
  • 00357599819002 ()
  • 57599-0819-00 ()
72080

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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