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; 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
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; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
7377
In Commercial Distribution

  • 40301937377011 ()
  • 00301937377013 ()
  • 0193-7377-01 ()
84413470

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

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

  • Glucose monitoring system IVD, home-use
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
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
Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution

  • 0193-6262-01 ()
  • 00301936262013 ()
85092979

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
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