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 Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • Glucose monitoring system IVD, home-use
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
"Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 CONTOUR® NEXT blood glucose test strips, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card, CONTOUR® NEXT control solution"
ASCENSIA DIABETES CARE US INC.
9658
Not in Commercial Distribution

  • 40301939658019 ()
  • 00301939658011 ()
  • 0193-9658-01 ()
90002904

  • Glucose monitoring system IVD, home-use
G5 Touchscreen Receiver
Dexcom, Inc.
STK-SR-001
Not in Commercial Distribution

  • 20386270000327 ()
  • 08627-0090-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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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