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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Reagent strips for urinalysis - glucose. 100 test strips.
ASCENSIA DIABETES CARE US INC.
2803
In Commercial Distribution

  • 40301932803218 ()
  • 00301932803210 ()
  • 10301932803217 ()
  • 0193-2802-21 ()
  • 00301932803012 ()
2871538

  • Urine glucose IVD, kit, rapid colorimetric, clinical
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
  • Blood lancing device tip
Control Solution - High, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7111B
Not in Commercial Distribution

  • 50301937111018 ()
  • 40301937111011 ()
  • 00301937111013 ()
  • 10301937111010 ()
  • 0193-7111-01 ()
6707466

  • Glucose IVD, control
Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7110B
Not in Commercial Distribution

  • 50301937110011 ()
  • 40301937110014 ()
  • 00301937110016 ()
  • 10301937110013 ()
  • 0193-7110-01 ()
6707458

  • Glucose IVD, control
Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7109B
Not in Commercial Distribution

  • 00301937109010 ()
  • 10301937109017 ()
  • 0193-7109-01 ()
  • 40301937109018 ()
  • 50301937109015 ()
6707431

  • Glucose IVD, control
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
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
Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2883
In Commercial Distribution

  • 40301932883500 ()
  • 00301932883502 ()
  • 10301932883509 ()
  • 0193-2882-50 ()
  • 00301932883014 ()
7081683

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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