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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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Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.
ASCENSIA DIABETES CARE US INC.
9697
Not in Commercial Distribution

  • 40301939697018 ()
  • 00301939697010 ()
  • 0193-9697-01 ()
84413500

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
9628
Not in Commercial Distribution

  • 40301939628012 ()
  • 00301939628014 ()
  • 0193-9628-01 ()
83785544

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9763
Not in Commercial Distribution

  • 40301939763010 ()
  • 00301939763012 ()
  • 0193-9763-01 ()
85012088

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution

  • 40301939736502 ()
  • 00301937311505 ()
  • 10301937311502 ()
  • 40301937311503 ()
  • 0193-7311-50 ()
  • 00301937311017 ()
  • 40301935540042 ()
83624710

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution

  • 40301939735253 ()
  • 00301937310256 ()
  • 10301937310253 ()
  • 40301937310254 ()
  • 0193-7310-25 ()
  • 00301937310010 ()
83623099

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution

  • 40301937357501 ()
  • 00301937309502 ()
  • 10301937309509 ()
  • 40301937309500 ()
  • 0193-7309-50 ()
  • 00301937309014 ()
83623080

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution

  • 40301937308503 ()
  • 00301937308505 ()
  • 10301937308502 ()
  • 0193-7308-50 ()
  • 00301937308017 ()
83623064

  • Glucose monitoring system IVD, home-use
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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