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

  • 00810123207077 ()
  • 810123207183 ()


  • Liposuction system cannula, reusable
OneTouch Verio®Level 4 Control Solution
LifeScan Europe GmbH
022-274
In Commercial Distribution

  • 20353885007775 ()
  • 00353885007771 ()
  • 53885-274-02 ()


  • Glucose monitoring system IVD, point-of-care
OneTouch Verio®Level 3 Control Solution
LifeScan Europe GmbH
022-273
In Commercial Distribution

  • 53885-273-02 ()
  • 00353885007764 ()
  • 20353885007768 ()
022-273

  • Glucose monitoring system IVD, point-of-care
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
One Touch Ultra Control Solution
LifeScan Europe GmbH
010-458
In Commercial Distribution

  • 20353885458027 ()
  • 00353885458023 ()
  • 53885-458-02 ()
  • 80353885458029 ()
010-458

  • Glucose monitoring system IVD, point-of-care
OneTouch Ultrasoft Lancets
LifeScan Europe GmbH
020-393
In Commercial Distribution

  • 20353885393106 ()
  • 00353885393102 ()
  • 53885-393-10 ()
  • 80353885393108 ()

  • Needle Gauge: 28 Gauge
020-393

  • Glucose monitoring system IVD, point-of-care
PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Prodigy Diabetes Care, LLC
051775
In Commercial Distribution

  • 00384840517752 ()
  • 30384840517753 ()
  • 08484-0517-75 ()
051775

  • Glucose monitoring system IVD, point-of-care
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
Prodigy Diabetes Care, LLC
051700
In Commercial Distribution

  • 00384840517004 ()
  • 10384840517001 ()
  • 08484-0517-00 ()
  • 00384843518008 ()
  • 50384840517009 ()
051700

  • Glucose monitoring system IVD, point-of-care
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 Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

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