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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 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

CONTOUR® NEXT ONE - 00301937824012

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

CONTOUR® NEXT ONE - 00301937818011

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

CONTOUR® NEXT EZ - 00301937553011

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

CONTOUR® NEXT GEN - 00301937383014

"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

CONTOUR® NEXT - 00301937283352

Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT EZ - 00301937252013

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); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
7252
In Commercial Distribution

  • 40301937252011 ()
  • 00301937252013 ()
  • 0193-7252-01 ()
83785579

  • Glucose monitoring system IVD, home-use

CONTOUR® - 00301937189012

Blood Glucose Monitoring System. For self-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.
7189
Not in Commercial Distribution

  • 40301937189010 ()
  • 00301937189012 ()
  • 0193-7189-01 ()
81492183

  • Glucose monitoring system IVD, home-use

CONTOUR® - 00301937151019

Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Blood Glucose Meter; User Guide; Quick Reference Guide; Lancing Device; 10 colored lancets (provided sterile); Log Book; Carrying Case; Warranty Card
ASCENSIA DIABETES CARE US INC.
7151H
Not in Commercial Distribution

  • 40301937151017 ()
  • 00301937151019 ()
  • 0193-7151-01 ()
82486543

  • Glucose monitoring system IVD, home-use
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