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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 blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips (UDI-DI: 20301930000370); MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9550
Not in Commercial Distribution

  • 40301939550016 ()
  • 00301939550018 ()
  • 0193-9550-01 ()
90007938

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In this kit you will find: CONTOUR® Blood Glucose Meter; 10 Blood Glucose Test Strips; Normal Control Solution; Quick Reference Guide; User Guide; Lancing Device; 10 Lancets (provided sterile); Logbook; Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
9545C
Not in Commercial Distribution

  • 40301939545012 ()
  • 00301939545014 ()
  • 0193-9545-01 ()
6707040

  • Glucose monitoring system IVD, home-use
"For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case"
ASCENSIA DIABETES CARE US INC.
7922
In Commercial Distribution

  • 40301937922013 ()
  • 00301937922015 ()
  • 0193-7922-01 ()
90010385

  • 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; 20 CONTOUR® NEXT Blood Glucose Test Strips; MICROLET® NEXT Lancing Device; 20 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
ASCENSIA DIABETES CARE US INC.
7828
In Commercial Distribution

  • 40301937828018 ()
  • 00301937828010 ()
  • 0193-7828-01 ()
90007942

  • 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; MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
ASCENSIA DIABETES CARE US INC.
7825
In Commercial Distribution

  • 40301937825017 ()
  • 00301937825019 ()
  • 0193-7825-01 ()
90007939

  • 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; 20 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 20 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.
ASCENSIA DIABETES CARE US INC.
7824
Not in Commercial Distribution

  • 40301937824010 ()
  • 00301937824012 ()
  • 0193-7824-01 ()
90001779

  • 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; 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.
ASCENSIA DIABETES CARE US INC.
7818
Not in Commercial Distribution

  • 00301937818011 ()
  • 0193-7818-01 ()
  • 40301937818019 ()
85012037

  • 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; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Carrying Case
ASCENSIA DIABETES CARE US INC.
7553
In Commercial Distribution

  • 40301937553019 ()
  • 00301937553011 ()
  • 0193-7553-01 ()
90007941

  • Glucose monitoring system IVD, home-use
"For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 20 CONTOUR® NEXT blood glucose test strips, Lancing Device, 20 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card"
ASCENSIA DIABETES CARE US INC.
7383
In Commercial Distribution

  • 40301937383012 ()
  • 00301937383014 ()
  • 0193-7383-01 ()
90004850

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
7379
In Commercial Distribution

  • 40301937379015 ()
  • 00301937379017 ()
  • 0193-7379-01 ()
81668523

  • Glucose monitoring system IVD, home-use
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