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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Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Unistrip Technologies, LLC
038600
In Commercial Distribution

  • 00681131304863 ()
  • 00681131104869 ()
  • 90681131104862 ()
  • 30681131104860 ()
  • 10681131104866 ()
  • 49035-0386-00 ()
038600

  • Glucose IVD, kit, electrometry
Blood Glucose Test strips. 25 test strips.
ASCENSIA DIABETES CARE US INC.
7070A
Not in Commercial Distribution

  • 40301939725254 ()
  • 00301937070259 ()
  • 10301937070256 ()
  • 40301937070257 ()
  • 0193-7070-25 ()
  • 00301937070013 ()
6707105

  • Glucose monitoring system IVD, home-use
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-270
In Commercial Distribution

  • 20353885007737 ()
  • 00353885007733 ()
  • 80353885007739 ()
  • 53885-270-25 ()
022-270

  • 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
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.
7098C
In Commercial Distribution

  • 40301937098503 ()
  • 00301937098505 ()
  • 10301937098502 ()
  • 0193-7098-50 ()
  • 00301937098017 ()
6707229

  • 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 - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
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.
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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