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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 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
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
Prodigy Diabetes Care, LLC
051700
In Commercial Distribution

  • 00384840517004 ()
  • 10384840517001 ()
  • 08484-0517-00 ()
  • 00384843518008 ()
  • 50384840517009 ()
051700

  • Glucose monitoring system IVD, point-of-care
PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Prodigy Diabetes Care, LLC
051775
In Commercial Distribution

  • 00384840517752 ()
  • 30384840517753 ()
  • 08484-0517-75 ()
051775

  • Glucose monitoring system IVD, point-of-care
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution

  • 40301939736502 ()
  • 00301937311505 ()
  • 10301937311502 ()
  • 40301937311503 ()
  • 0193-7311-50 ()
  • 00301937311017 ()
  • 40301935540042 ()
83624710

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution

  • 40301939735253 ()
  • 00301937310256 ()
  • 10301937310253 ()
  • 40301937310254 ()
  • 0193-7310-25 ()
  • 00301937310010 ()
83623099

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution

  • 40301937357501 ()
  • 00301937309502 ()
  • 10301937309509 ()
  • 40301937309500 ()
  • 0193-7309-50 ()
  • 00301937309014 ()
83623080

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution

  • 40301937308503 ()
  • 00301937308505 ()
  • 10301937308502 ()
  • 0193-7308-50 ()
  • 00301937308017 ()
83623064

  • Glucose monitoring system IVD, home-use
G5 Touchscreen Receiver
Dexcom, Inc.
STK-SR-001
Not in Commercial Distribution

  • 20386270000327 ()
  • 08627-0090-11 ()


  • 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 ONE Meter; MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
ASCENSIA DIABETES CARE US INC.
7825
In Commercial Distribution

  • 40301937825017 ()
  • 00301937825019 ()
  • 0193-7825-01 ()
90007939

  • Glucose monitoring system IVD, home-use
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