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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 GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card.
ASCENSIA DIABETES CARE US INC.
7917
In Commercial Distribution

  • 00301937917011 ()
  • 40301937917019 ()
90002902

  • Glucose monitoring system IVD, home-use
Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7594
In Commercial Distribution

  • 40301937594012 ()
  • 00301937594014 ()
90006349

  • Glucose monitoring system IVD, home-use
Control Solution - Level 1. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7593
In Commercial Distribution

  • 40301937593015 ()
  • 00301937593017 ()
90006348

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
7584
In Commercial Distribution

  • 40301937584501 ()
  • 00301937584503 ()
  • 20231937584507 ()
90012479

  • 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
"Contour Plus Blue Blood Glucose monitoring System For Self- testing, mornitoring and management of blood glucose. Kit Contains: -Contour Plus Blue blood glucose meter (product of Indonesia) -Micolet Next Lancing device (Product of Poland) -User Guide -Quick Reference Guide - Carrying Case (Product of China) Control solutions are required but not included and must be purchased separately"
ASCENSIA DIABETES CARE US INC.
7036
In Commercial Distribution

  • 40301937036017 ()
  • 00301937036019 ()
90008381

  • Glucose monitoring system IVD, home-use
"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China)"
ASCENSIA DIABETES CARE US INC.
7035
In Commercial Distribution

  • 40301937035027 ()
  • 00301937035029 ()
  • 00301937035012 ()
90006207

  • Glucose monitoring system IVD, home-use
"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China) Contour Plus control solution (Product of USA)"
ASCENSIA DIABETES CARE US INC.
7035
Not in Commercial Distribution

  • 00301937035012 ()
  • 40301937035010 ()
90006207

  • Glucose monitoring system IVD, home-use
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
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