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.
7111B
Not in Commercial Distribution

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

  • 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
Blood Glucose Test strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
7099C
Not in Commercial Distribution

  • 40301937099500 ()
  • 00301937099502 ()
  • 10301937099509 ()
  • 0193-7099-50 ()
  • 00301937099014 ()
6707245

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
7097C
Not in Commercial Distribution

  • 40301937097506 ()
  • 00301937097508 ()
  • 10301937097505 ()
  • 0193-7097-50 ()
  • 00301937097010 ()
6707202

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - RDC # 0193-7090-21).
ASCENSIA DIABETES CARE US INC.
7080G
In Commercial Distribution

  • 40301939727210 ()
  • 00301937090219 ()
  • 10301937080507 ()
  • 40301939726503 ()
  • 00301937080500 ()
  • 40301937090217 ()
  • 40301937080508 ()
  • 0193-7080-50 ()
  • 00301937080012 ()
  • 40301939603040 ()
  • 40301939602043 ()
6707113

  • Glucose monitoring system IVD, home-use
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
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
2881
In Commercial Distribution

  • 40301932881216 ()
  • 00301932881218 ()
  • 10301932881215 ()
  • 0193-2880-21 ()
  • 00301932881010 ()
5778865

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Reagent strips for urinalysis - glucose. 50 test strips.
ASCENSIA DIABETES CARE US INC.
2806
In Commercial Distribution

  • 40301932806509 ()
  • 00301932806501 ()
  • 10301932806508 ()
  • 0193-2802-50 ()
  • 00301932806013 ()
8488841

  • Urine glucose IVD, kit, rapid colorimetric, clinical
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 - 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
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