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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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Urine Analyzer 120
BTNX Inc
U120
In Commercial Distribution

  • 00722066001936 ()
  • 00722066005064 ()


  • Urine analyser IVD, point-of-care
Urine Analyzer 500
BTNX Inc
UA-500
In Commercial Distribution

  • 00722066001219 ()
  • 00722066005071 ()


  • Urine analyser IVD, point-of-care
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
BTNX Inc
U10.1-1S100
In Commercial Distribution

  • 00722066001172 ()
  • 00722066003787 ()
U10.1-1S100

  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
LIFEPAK CR PLUS SEMI EXTENDED PROMPTS
PHYSIO-CONTROL, INC.
99403
Not in Commercial Distribution

  • 00721902878879 ()
99403-000112

  • Rechargeable public semi-automated external defibrillator
PACKAGE-LPCR,SEMI, EXTENDED PROMPTS
PHYSIO-CONTROL, INC.
80403
Not in Commercial Distribution

  • 00721902875274 ()
80403-000112

  • Rechargeable public semi-automated external defibrillator
15AACAABAABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 00883873871775 ()
99577-001949

  • Physiologic-monitoring defibrillation system
15AABAABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 00883873871768 ()
99577-001950

  • Physiologic-monitoring defibrillation system
15AABAABBABBBABAAAAAAAAFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 00883873871751 ()
99577-001951

  • Physiologic-monitoring defibrillation system
15AACAABBABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 00883873871744 ()
99577-001952

  • Physiologic-monitoring defibrillation system
15AABBABAABBBAAAAAAAAAAFLP15 MONITOR/DEFIB
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 00883873871737 ()
99577-001953

  • Physiologic-monitoring defibrillation system
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