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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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OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
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: Ketone
ASCENSIA DIABETES CARE US INC.
2880
In Commercial Distribution

  • 40301932880509 ()
  • 00301932880501 ()
  • 10301932880508 ()
  • 0193-2880-50 ()
  • 00301932880013 ()
9549534

  • Urine ketone IVD, kit, rapid colorimetric, clinical
OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.
LifeScan Europe GmbH
024-174
In Commercial Distribution

  • 20353885012038 ()
  • 00353885012034 ()
  • 80353885012030 ()
  • 53885-174-50 ()
024-174

  • Glucose IVD, kit, electrometry
OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-268
In Commercial Distribution

  • 20353885007713 ()
  • 00353885007719 ()
  • 53885-854-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
022-268

  • Glucose monitoring system IVD, home-use
  • Glucose IVD, control
  • Manual blood lancing device, reusable
  • Blood lancing device tip
  • Glucose IVD, kit, electrometry
OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-267
In Commercial Distribution

  • 20353885007706 ()
  • 00353885007702 ()
  • 53885-267-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-267

  • Glucose monitoring system IVD, home-use
  • Blood lancing device tip
  • Manual blood lancing device, reusable
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; Glucose
ASCENSIA DIABETES CARE US INC.
2882
In Commercial Distribution

  • 40301932882213 ()
  • 00301932882215 ()
  • 10301932882212 ()
  • 0193-2882-21 ()
  • 00301932882017 ()
15197

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters. For Kaiser Permanente Members Only
LifeScan Europe GmbH
023-061
In Commercial Distribution

  • 20353885010485 ()
  • 00353885010481 ()
  • 80353885010487 ()
  • 53885-061-50 ()
023-061

  • Glucose IVD, kit, electrometry
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