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

  • 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
Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
Prodigy Diabetes Care, LLC
75050
In Commercial Distribution

  • 00384841732000 ()
  • 08484-0750-50 ()
  • 00384840750500 ()
  • 30384840750501 ()
075050

  • Glucose monitoring system IVD, home-use
Prodigy AutoCode Blood Glucose Monitoring System
Prodigy Diabetes Care, LLC
074300
In Commercial Distribution

  • 00384841518505 ()
  • 00384843743004 ()
  • 00384840743007 ()
  • 08484-0743-00 ()
074300

  • Glucose monitoring system IVD, home-use
PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Prodigy Diabetes Care, LLC
051775
In Commercial Distribution

  • 00384840517752 ()
  • 30384840517753 ()
  • 08484-0517-75 ()
051775

  • Glucose monitoring system IVD, point-of-care
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
Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
Prodigy Diabetes Care, LLC
010500
In Commercial Distribution

  • 00384840105003 ()
  • 00384841104005 ()
  • 00384844105009 ()
  • 3 84840 10500 ()
010500

  • Glucose monitoring system IVD, home-use
1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
Prodigy Diabetes Care, LLC
010400
In Commercial Distribution

  • 00384843104003 ()
  • 00384840104006 ()
  • 00384844104002 ()
  • 3 84840 10400 ()
010400

  • 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
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