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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 Verio Flex - 00353885010979

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

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

OneTouch Verio Flex - 00353885010719

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

Element™ Meter - 08809115908452

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

Element™Plus Meter - 08809115908971

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

CONTOUR® NEXT ONE - 00301939767010

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
ASCENSIA DIABETES CARE US INC.
9767
Not in Commercial Distribution

  • 40301939767018 ()
  • 00301939767010 ()
  • 0193-9767-01 ()
85977059

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT ONE - 00301939765016

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

CONTOUR® NEXT ONE - 00301939763012

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

CONTOUR® NEXT GEN - 00301939732018

"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

CONTOUR® NEXT - 00301939697010

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

CONTOUR® NEXT GEN - 00301939658011

"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
In Commercial Distribution

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

  • Glucose monitoring system IVD, home-use
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