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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One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-140
In Commercial Distribution

  • 20353885006839 ()
  • 00353885006835 ()
  • 53885-140-20 ()
  • 80353885006831 ()

  • Needle Gauge: 28 Gauge


  • Manual blood lancing device, single-use
One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-139
In Commercial Distribution

  • 53885-139-20 ()
  • 00353885006828 ()
  • 80353885006824 ()
  • 20353885006822 ()

  • Needle Gauge: 21 Gauge


  • Manual blood lancing device, single-use
One Touch Ultra Control Solution
LifeScan Europe GmbH
021-416
In Commercial Distribution

  • 20353885006235 ()
  • 00353885006231 ()
  • 53885-937-01 ()
021-416

  • Glucose monitoring system IVD, point-of-care
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-963
In Commercial Distribution

  • 20353885004187 ()
  • 00353885004183 ()
  • 80353885004189 ()
  • 30353885004184 ()
  • 53885-963-50 ()
020-963

  • Glucose IVD, kit, electrometry
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
Abbott SF Single Use Lancing Device 200ct, US
ABBOTT DIABETES CARE INC
78632
In Commercial Distribution

  • 10357599000698 ()
  • 57599-0833-00 ()
  • 00357599833008 ()
  • 30357599833009 ()
78632

  • Manual blood lancing device, single-use
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
FreeStyle Precision Neo Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71750
In Commercial Distribution

  • 30357599000357 ()
  • 00357599000356 ()
  • 57599-0000-35 ()
  • 10357599000353 ()
71750

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Precision Neo Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71749
In Commercial Distribution

  • 30357599000340 ()
  • 00357599000349 ()
  • 57599-0000-34 ()
  • 10357599000346 ()
71749

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale
ABBOTT DIABETES CARE INC
71748
In Commercial Distribution

  • 30357599000333 ()
  • 00357599000332 ()
  • 57599-0000-33 ()
  • 10357599000339 ()
71748

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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