SEARCH RESULTS FOR: gs1(218 results)

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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 IQ - 00353885007702

OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-267
In Commercial Distribution

  • 20353885007706 ()
  • 00353885007702 ()
  • 53885-267-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-267

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

OneTouch Ultra - 00353885006231

One Touch Ultra Control Solution
LifeScan Europe GmbH
021-416
In Commercial Distribution

  • 20353885006235 ()
  • 00353885006231 ()
  • 53885-937-01 ()
021-416

  • Glucose monitoring system IVD, point-of-care

OneTouch Ultra2 - 00353885000277

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

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 EZ - 00301939628014

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; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
9628
Not in Commercial Distribution

  • 40301939628012 ()
  • 00301939628014 ()
  • 0193-9628-01 ()
83785544

  • Glucose monitoring system IVD, home-use

CONTOUR® - 00301939556010

Blood Glucose Monitoring System. For self-testing, 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.
9556C
In Commercial Distribution

  • 40301939556018 ()
  • 00301939556010 ()
  • 0193-9556-01 ()
6707059

  • Glucose monitoring system IVD, home-use
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