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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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CONTOUR® NEXT GEN - 00301939732018

"For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, CONTOUR® NEXT control solution"
ASCENSIA DIABETES CARE US INC.
9732
Not in Commercial Distribution

  • 40301939732016 ()
  • 00301939732018 ()
  • 0193-9732-01 ()
90010386

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 00301939697010

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

CONTOUR® NEXT GEN - 00301939658011

"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
In Commercial Distribution

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

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT EZ - 00301939628014

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

CONTOUR® - 00301939556010

Blood Glucose Monitoring System. For self-testing, monitoring and management of blood glucose. Contents: CONTOUR® Blood Glucose Meter; Quick Reference Guide; User Guide; Log Book; Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
9556C
In Commercial Distribution

  • 40301939556018 ()
  • 00301939556010 ()
  • 0193-9556-01 ()
6707059

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT ONE - 00301939550018

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

CONTOUR® - 00301939545014

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

CONTOUR® NEXT GEN - 00301937922015

"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

CONTOUR® NEXT ONE - 00301937828010

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

CONTOUR® NEXT ONE - 00301937825019

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
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