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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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
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908452 ()
  • 8522-0000-22 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
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
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9765
In Commercial Distribution

  • 40301939765014 ()
  • 00301939765016 ()
  • 0193-9765-01 ()
85602314

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9763
Not in Commercial Distribution

  • 40301939763010 ()
  • 00301939763012 ()
  • 0193-9763-01 ()
85012088

  • Glucose monitoring system IVD, home-use
"For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, CONTOUR® NEXT control solution"
ASCENSIA DIABETES CARE US INC.
9732
Not in Commercial Distribution

  • 40301939732016 ()
  • 00301939732018 ()
  • 0193-9732-01 ()
90010386

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.
ASCENSIA DIABETES CARE US INC.
9697
Not in Commercial Distribution

  • 40301939697018 ()
  • 00301939697010 ()
  • 0193-9697-01 ()
84413500

  • Glucose monitoring system IVD, home-use
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