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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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KETO-DIASTIX® - 10301932882212

Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2882
In Commercial Distribution

  • 40301932882213 ()
  • 00301932882215 ()
  • 10301932882212 ()
  • 0193-2882-21 ()
  • 00301932882017 ()
15197

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

DIASTIX® - 10301932806508

Reagent strips for urinalysis - glucose. 50 test strips.
ASCENSIA DIABETES CARE US INC.
2806
In Commercial Distribution

  • 40301932806509 ()
  • 00301932806501 ()
  • 10301932806508 ()
  • 0193-2802-50 ()
  • 00301932806013 ()
8488841

  • Urine glucose IVD, kit, rapid colorimetric, clinical

DIASTIX® - 10301932803217

Reagent strips for urinalysis - glucose. 100 test strips.
ASCENSIA DIABETES CARE US INC.
2803
In Commercial Distribution

  • 40301932803218 ()
  • 00301932803210 ()
  • 10301932803217 ()
  • 0193-2802-21 ()
  • 00301932803012 ()
2871538

  • Urine glucose IVD, kit, rapid colorimetric, clinical

FreeStyle Libre 3 - 00357599842000

FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
78754
In Commercial Distribution

  • 30357599842001 ()
  • 00357599842000 ()
  • 57599-0842-00 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Abbott - 00357599833008

Abbott SF Single Use Lancing Device 200ct, US
ABBOTT DIABETES CARE INC
78632
In Commercial Distribution

  • 10357599000698 ()
  • 57599-0833-00 ()
  • 00357599833008 ()
  • 30357599833009 ()
78632

  • Manual blood lancing device, single-use

FreeStyle Libre 3 - 00357599820008

FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
72079
In Commercial Distribution

  • 57599-0820-00 ()
  • 00357599820008 ()
72079

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 3 - 00357599819002

FreeStyle Libre 3 Sensor Kit NFRS
ABBOTT DIABETES CARE INC
72080
In Commercial Distribution

  • 30357599819003 ()
  • 00357599819002 ()
  • 57599-0819-00 ()
72080

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 3 - 00357599818005

FreeStyle Libre 3 Sensor Kit US
ABBOTT DIABETES CARE INC
72081
In Commercial Distribution

  • 30357599818006 ()
  • 00357599818005 ()
  • 57599-0818-00 ()
72081

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Abbott - 00357599000691

Abbott SF Single Use Lancing Device
ABBOTT DIABETES CARE INC
70901
Not in Commercial Distribution

  • 30357599000692 ()
  • 00357599000691 ()
  • 99073-0709-01 ()
  • 10357599000698 ()
70901

  • Glucose monitoring system IVD, home-use

FreeStyle Precision Neo - 00357599000349

FreeStyle Precision Neo Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71749
In Commercial Distribution

  • 30357599000340 ()
  • 00357599000349 ()
  • 57599-0000-34 ()
  • 10357599000346 ()
71749

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