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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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Blood Glucose Test strips. 25 test strips.
ASCENSIA DIABETES CARE US INC.
7070A
Not in Commercial Distribution

  • 40301939725254 ()
  • 00301937070259 ()
  • 10301937070256 ()
  • 40301937070257 ()
  • 0193-7070-25 ()
  • 00301937070013 ()
6707105

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1468A
Not in Commercial Distribution

  • 40301931468500 ()
  • 00301931468502 ()
  • 10301931468509 ()
  • 20301931468506 ()
  • 0193-1468-50 ()
  • 00301931468014 ()
56853247

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1467A
Not in Commercial Distribution

  • 40301931467503 ()
  • 00301931467505 ()
  • 10301931467502 ()
  • 20301931467509 ()
  • 0193-1467-50 ()
  • 00301931467017 ()
56853239

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
ASCENSIA DIABETES CARE US INC.
1466A
Not in Commercial Distribution

  • 00301931466218 ()
  • 10301931466215 ()
  • 20301931466212 ()
  • 0193-1466-21 ()
  • 00301931466010 ()
  • 40301931466216 ()
56853220

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1465A
Not in Commercial Distribution

  • 40301931465509 ()
  • 00301931465501 ()
  • 10301931465508 ()
  • 20301931465505 ()
  • 0193-1465-50 ()
  • 00301931465013 ()
56853212

  • Glucose monitoring system IVD, home-use
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • 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 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
Not in Commercial Distribution

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

  • Glucose monitoring system IVD, home-use
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
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
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70851
Not in Commercial Distribution

  • 30699073000843 ()
  • 00699073000842 ()
  • 99073-0708-51 ()
70851

  • Electrical-only medical device connection cable, reusable
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