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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; 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. 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. 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-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
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; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9765
In Commercial Distribution

  • 40301939765014 ()
  • 00301939765016 ()
  • 0193-9765-01 ()
85602314

  • 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 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
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-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
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
SMD Manufacturing LLC
RP-MKITQ4-1
In Commercial Distribution

  • 10850001175217 ()
  • 00850001175210 ()
  • 73573-155-14 ()


  • Oral care kit, single-use
  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
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
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