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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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
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. 10 test strips.
ASCENSIA DIABETES CARE US INC.
9507C
Not in Commercial Distribution

  • 40301939507102 ()
  • 00301939507104 ()
  • 10301939507101 ()
  • 0193-9507-10 ()
  • 00301939507012 ()
6707261

  • Glucose monitoring system IVD, home-use
Control Solution - Level 1. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7315
In Commercial Distribution

  • 50301937315010 ()
  • 40301937315013 ()
  • 00301937315015 ()
  • 10301937315012 ()
  • 0193-7315-01 ()
83624826

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 10 Test Strips.
ASCENSIA DIABETES CARE US INC.
7313
In Commercial Distribution

  • 10301937313100 ()
  • 40301937313101 ()
  • 00301937313103 ()
  • 0193-7313-10 ()
  • 00301937313011 ()
83624796

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution

  • 40301939736502 ()
  • 00301937311505 ()
  • 10301937311502 ()
  • 40301937311503 ()
  • 0193-7311-50 ()
  • 00301937311017 ()
  • 40301935540042 ()
83624710

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution

  • 40301939735253 ()
  • 00301937310256 ()
  • 10301937310253 ()
  • 40301937310254 ()
  • 0193-7310-25 ()
  • 00301937310010 ()
83623099

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution

  • 40301937357501 ()
  • 00301937309502 ()
  • 10301937309509 ()
  • 40301937309500 ()
  • 0193-7309-50 ()
  • 00301937309014 ()
83623080

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution

  • 40301937308503 ()
  • 00301937308505 ()
  • 10301937308502 ()
  • 0193-7308-50 ()
  • 00301937308017 ()
83623064

  • Glucose monitoring system IVD, home-use
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