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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Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
7379
In Commercial Distribution

  • 40301937379015 ()
  • 00301937379017 ()
  • 0193-7379-01 ()
81668523

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
7377
In Commercial Distribution

  • 40301937377011 ()
  • 00301937377013 ()
  • 0193-7377-01 ()
84413470

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
7252
In Commercial Distribution

  • 40301937252011 ()
  • 00301937252013 ()
  • 0193-7252-01 ()
83785579

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. For self-monitoring and management of blood glucose. Contents: CONTOUR® Blood Glucose Meter; Quick Reference Guide; User Guide; Log Book; Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
7189
Not in Commercial Distribution

  • 40301937189010 ()
  • 00301937189012 ()
  • 0193-7189-01 ()
81492183

  • Glucose monitoring system IVD, home-use
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
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
Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
Prodigy Diabetes Care, LLC
75050
In Commercial Distribution

  • 00384841732000 ()
  • 08484-0750-50 ()
  • 00384840750500 ()
  • 30384840750501 ()
075050

  • Glucose monitoring system IVD, home-use
Prodigy AutoCode Blood Glucose Monitoring System
Prodigy Diabetes Care, LLC
074300
In Commercial Distribution

  • 00384841518505 ()
  • 00384843743004 ()
  • 00384840743007 ()
  • 08484-0743-00 ()
074300

  • Glucose monitoring system IVD, home-use
Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
Prodigy Diabetes Care, LLC
010500
In Commercial Distribution

  • 00384840105003 ()
  • 00384841104005 ()
  • 00384844105009 ()
  • 3 84840 10500 ()
010500

  • Glucose monitoring system IVD, home-use
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