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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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CONTOUR® - 00301937151019

Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Blood Glucose Meter; User Guide; Quick Reference Guide; Lancing Device; 10 colored lancets (provided sterile); Log Book; Carrying Case; Warranty Card
ASCENSIA DIABETES CARE US INC.
7151H
Not in Commercial Distribution

  • 40301937151017 ()
  • 00301937151019 ()
  • 0193-7151-01 ()
82486543

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT LINK 2.4 - 00301936262013

Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution

  • 0193-6262-01 ()
  • 00301936262013 ()
85092979

  • Glucose monitoring system IVD, home-use

Abbott - 00357599000691

Abbott SF Single Use Lancing Device
ABBOTT DIABETES CARE INC
70901
Not in Commercial Distribution

  • 30357599000692 ()
  • 00357599000691 ()
  • 99073-0709-01 ()
  • 10357599000698 ()
70901

  • Glucose monitoring system IVD, home-use

OneTouch Verio Flex - 00353885012799

OneTouch Verio Flex Blood Glucose Monitoring System
LifeScan Europe GmbH
024-336
In Commercial Distribution

  • 20353885012793 ()
  • 00353885012799 ()
  • 53885-336-01 ()
024-336

  • Glucose monitoring system IVD, home-use

OneTouch Ultra2 Blood Glucose Monitoring System. - 00353885011860

OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-047
In Commercial Distribution

  • 20353885011864 ()
  • 00353885011860 ()
  • 53885-047-01 ()

  • Do not refrigerate
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-047

  • Glucose monitoring system IVD, home-use

OneTouch Ultra2 - 00353885011853

OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-046
In Commercial Distribution

  • 20353885011857 ()
  • 00353885011853 ()
  • 53885-046-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-046

  • Glucose monitoring system IVD, home-use

OneTouch Verio Flex - 00353885011846

OneTouch Verio Flex Blood Glucose Monitoring System.
LifeScan Europe GmbH
024045
In Commercial Distribution

  • 20353885011840 ()
  • 00353885011846 ()
  • 53885-045-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-045

  • Glucose monitoring system IVD, home-use

OneTouch Verio Flex - 00353885011839

OneTouch Verio Flex Blood Glucose Monitoring System.
LifeScan Europe GmbH
024044
In Commercial Distribution

  • 20353885011833 ()
  • 00353885011839 ()
  • 53885-044-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-044

  • Glucose monitoring system IVD, home-use

OneTouch Verio Blood Glucose Monitoring System. - 00353885011815

OneTouch Verio Blood Glucose Monitoring System.
LifeScan Europe GmbH
024042
In Commercial Distribution

  • 20353885011819 ()
  • 00353885011815 ()
  • 53885-042-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
02404201

  • Glucose monitoring system IVD, home-use

OneTouch Verio Blood Glucose Monitoring System. - 00353885011808

OneTouch Verio Blood Glucose Monitoring System.
LifeScan Europe GmbH
024041
In Commercial Distribution

  • 20353885011802 ()
  • 00353885011808 ()
  • 53885-041-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
02404101

  • Glucose monitoring system IVD, home-use
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