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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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KETO-DIASTIX® - 10301932882212

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 IQ - 00353885007719

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 - 00353885007702

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

OneTouch Ultra2 - 00353885000277

OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-098
In Commercial Distribution

  • 20353885000271 ()
  • 00353885000277 ()
  • 53885-448-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-098

  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use

OneTouch Ultra2 - 00353885008853

OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-100
In Commercial Distribution

  • 20353885008857 ()
  • 00353885008853 ()
  • 53885-452-10 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
021-100

  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use

OneTouch Ultra2 - 00353885010016

OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
022-965
In Commercial Distribution

  • 20353885010010 ()
  • 00353885010016 ()
  • 53885-296-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
022-965

  • Glucose IVD, kit, electrometry
  • Glucose analyser IVD, home-use

Adler Instrument Company - 00810123207084

Zumi 4.5 Uterine Manipulator/Injector
Adler, Inc.
AI-611
In Commercial Distribution

  • 00810123207084 ()
  • 00810123207176 ()


  • Drug-delivery iontophoresis patch

OneTouch Verio Flex - 00353885011761

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-932
In Commercial Distribution

  • 20353885011765 ()
  • 00353885011761 ()
  • 53885-932-02 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
023-932

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Glucose monitoring system IVD, home-use

FreeStyle - 00699073130013

FreeStyle Lancets 28 Gauge
ABBOTT DIABETES CARE INC
70469
In Commercial Distribution

  • 30699073130014 ()
  • 00699073130013 ()
  • 99073-0130-01 ()
  • 10699073130010 ()
70469

  • Blood lancing device tip

MICROLET® - 00301936586218

Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.
ASCENSIA DIABETES CARE US INC.
6586 / 6586W
In Commercial Distribution

  • 40301936586124 ()
  • 00301936586218 ()
  • 40301936586216 ()
  • 0193-6586-21 ()
  • 00301936586010 ()
81264857, 81264954 (US)

  • Blood lancing device tip
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