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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FreeStyle Libre Pro Reader Kit US DOD
ABBOTT DIABETES CARE INC
71760
In Commercial Distribution

  • 30357599000418 ()
  • 00357599000417 ()
  • 57599-0000-41 ()
71760

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Reader Kit US DOD
ABBOTT DIABETES CARE INC
71739
Not in Commercial Distribution

  • 30357599000241 ()
  • 00357599000240 ()
  • 57599-0000-24 ()
71739

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Reader Kit US
ABBOTT DIABETES CARE INC
71701
Not in Commercial Distribution

  • 30357599000227 ()
  • 00357599000226 ()
  • 57599-0000-22 ()
71701

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Reader Kit US
ABBOTT DIABETES CARE INC
71525
Not in Commercial Distribution

  • 30357599000210 ()
  • 00357599000219 ()
  • 57599-0000-21 ()
71525

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Sensor Kit
ABBOTT DIABETES CARE INC
71702
Not in Commercial Distribution

  • 30357599000203 ()
  • 00357599000202 ()
  • 57599-0000-20 ()
71702

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre Sensor Kit
ABBOTT DIABETES CARE INC
71536
Not in Commercial Distribution

  • 30357599000197 ()
  • 00357599000196 ()
  • 57599-0000-19 ()
71536

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
"Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 CONTOUR® NEXT blood glucose test strips, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card, CONTOUR® NEXT control solution"
ASCENSIA DIABETES CARE US INC.
9658
Not in Commercial Distribution

  • 40301939658019 ()
  • 00301939658011 ()
  • 0193-9658-01 ()
90002904

  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
LifeScan Europe GmbH
023-194
In Commercial Distribution

  • 20353885010713 ()
  • 00353885010719 ()
  • 53885-194-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
  • Needle Gauge: 30 Gauge
023-194

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-913
In Commercial Distribution

  • 20353885002688 ()
  • 00353885002684 ()
  • 53885-913-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-913

  • Glucose analyser IVD, home-use
  • Manual blood lancing device, reusable
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-422
In Commercial Distribution

  • 20353885001315 ()
  • 00353885001311 ()
  • 53885-422-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-422

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