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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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Control Solution - High, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1491A
Not in Commercial Distribution

  • 50301931491017 ()
  • 40301931491010 ()
  • 00301931491012 ()
  • 10301931491019 ()
  • 0193-1491-01 ()
81007218

  • Glucose IVD, control
Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1490A
Not in Commercial Distribution

  • 50301931490010 ()
  • 40301931490013 ()
  • 00301931490015 ()
  • 10301931490012 ()
  • 0193-1490-01 ()
81007196

  • Glucose IVD, control
Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1489A
Not in Commercial Distribution

  • 50301931489014 ()
  • 40301931489017 ()
  • 00301931489019 ()
  • 10301931489016 ()
  • 0193-1489-01 ()
81007188

  • Glucose IVD, control
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1468A
Not in Commercial Distribution

  • 40301931468500 ()
  • 00301931468502 ()
  • 10301931468509 ()
  • 20301931468506 ()
  • 0193-1468-50 ()
  • 00301931468014 ()
56853247

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1467A
Not in Commercial Distribution

  • 40301931467503 ()
  • 00301931467505 ()
  • 10301931467502 ()
  • 20301931467509 ()
  • 0193-1467-50 ()
  • 00301931467017 ()
56853239

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
ASCENSIA DIABETES CARE US INC.
1466A
Not in Commercial Distribution

  • 00301931466218 ()
  • 10301931466215 ()
  • 20301931466212 ()
  • 0193-1466-21 ()
  • 00301931466010 ()
  • 40301931466216 ()
56853220

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1465A
Not in Commercial Distribution

  • 40301931465509 ()
  • 00301931465501 ()
  • 10301931465508 ()
  • 20301931465505 ()
  • 0193-1465-50 ()
  • 00301931465013 ()
56853212

  • Glucose monitoring system IVD, home-use
FreeStyle Libre 2 Plus Sensor Not For Retail Sale
ABBOTT DIABETES CARE INC
78749
In Commercial Distribution

  • 30357599836000 ()
  • 00357599836009 ()
  • 57599-0836-00 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 Plus Sensor
ABBOTT DIABETES CARE INC
78747
In Commercial Distribution

  • 30357599835003 ()
  • 00357599835002 ()
  • 57599-0835-00 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

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

  • Glucose monitoring system IVD, home-use
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