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. 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. 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
Not in Commercial Distribution

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

  • Glucose monitoring system IVD, home-use
FreeStyle Lite Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
70827
In Commercial Distribution

  • 30699073708275 ()
  • 00699073708274 ()
  • 99073-0708-27 ()
  • 10699073708271 ()
  • 40699073708272 ()
70827

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Lite Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
70822
In Commercial Distribution

  • 40699073708227 ()
  • 00699073708229 ()
  • 99073-0708-22 ()
  • 10699073708226 ()
  • 30699073708220 ()
70822

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
12101
In Commercial Distribution

  • 40699073121019 ()
  • 00699073121011 ()
  • 99073-0121-01 ()
  • 10699073121018 ()
  • 30699073121012 ()
12101

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
12050
In Commercial Distribution

  • 40699073120500 ()
  • 00699073120502 ()
  • 99073-0120-50 ()
  • 10699073120509 ()
  • 30699073120503 ()
12050

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
Prodigy Diabetes Care, LLC
051700
In Commercial Distribution

  • 00384840517004 ()
  • 10384840517001 ()
  • 08484-0517-00 ()
  • 00384843518008 ()
  • 50384840517009 ()
051700

  • Glucose monitoring system IVD, point-of-care
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99877
In Commercial Distribution

  • 30093815998779 ()
  • 00093815998778 ()
  • 57599-9877-5 ()
  • 10093815998775 ()
  • 40093815998776 ()
99877

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99728
In Commercial Distribution

  • 40093815997281 ()
  • 00093815997283 ()
  • 30093815997284 ()
  • 57599-9728-4 ()
  • 10093815997280 ()
99728

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
FreeStyle Precision Neo Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71581
In Commercial Distribution

  • 30093815715819 ()
  • 00093815715818 ()
  • 57599-1581-5 ()
  • 10093815715815 ()
  • 40093815715816 ()
71581

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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