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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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CONTOUR® NEXT ONE - 00301937824012

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 20 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.
ASCENSIA DIABETES CARE US INC.
7824
Not in Commercial Distribution

  • 40301937824010 ()
  • 00301937824012 ()
  • 0193-7824-01 ()
90001779

  • 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® 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 LINK 2.4 - 00301936262013

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

Adler Instrument Company - 00810123207077

Zami/Kronner 4.5 Uterine Manipulator
Adler, Inc.
AI-6003
In Commercial Distribution

  • 00810123207077 ()
  • 810123207183 ()


  • Liposuction system cannula, reusable

OneTouch Ultra2 - 00353885010511

OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
LifeScan Europe GmbH
023-065
In Commercial Distribution

  • 20353885010515 ()
  • 00353885010511 ()
  • 53885-065-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
023-065

  • Glucose analyser IVD, home-use

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

Precision Xtra - 00093815998785

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99878
In Commercial Distribution

  • 30093815998786 ()
  • 00093815998785 ()
  • 57599-9878-5 ()
  • 10093815998782 ()
99878

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use

Precision Xtra - 00093815998778

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99877
In Commercial Distribution

  • 30093815998779 ()
  • 00093815998778 ()
  • 57599-9877-5 ()
  • 10093815998775 ()
  • 40093815998776 ()
99877

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care

Precision Xtra - 00093815998389

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99838
In Commercial Distribution

  • 30093815998380 ()
  • 00093815998389 ()
  • 57599-9838-4 ()
  • 10093815998386 ()
99838

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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