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
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908964 ()
  • 08809115908957 ()
  • 8522-0000-64 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908452 ()
  • 8522-0000-22 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908438 ()
  • 8522-0000-23 ()
  • 08809115908445 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry
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
Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7314
In Commercial Distribution

  • 50301937314013 ()
  • 40301937314016 ()
  • 00301937314018 ()
  • 10301937314015 ()
  • 0193-7314-01 ()
83624818

  • Glucose IVD, control
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
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