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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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AFFINITY MEDICAL TECHNOLOGIES, LLC
CEMGB
In Commercial Distribution

  • 00850384007092 ()


  • Electrocardiographic lead set, reusable
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software
E8089 Crea B electrode for ABL8XX
Radiometer Medical ApS
945-663
In Commercial Distribution

  • 05700699456632 ()
945-663

  • Creatinine IVD, reagent
E8088 Crea A electrode for ABL8XX
Radiometer Medical ApS
945-662
In Commercial Distribution

  • 05700699456625 ()
945-662

  • Creatinine IVD, reagent
D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution

  • 05700699420664 ()
  • 55700699420669 ()
942-066

  • Lactate electrode IVD
D7066 Glu membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-065
In Commercial Distribution

  • 05700699420657 ()
  • 55700699420652 ()
942-065

  • Glucose IVD, kit, electrometry
D744 Cl membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-061
In Commercial Distribution

  • 05700699420619 ()
  • 55700699420614 ()
942-061

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
D733 Ca membrane box (4units) for ABL7XX/8XX
Radiometer Medical ApS
942-060
In Commercial Distribution

  • 05700699420602 ()
  • 55700699420607 ()
942-060

  • Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)
D722 K membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-059
In Commercial Distribution

  • 05700699420596 ()
  • 55700699420591 ()
942-059

  • Potassium (K+) IVD, kit, ion-selective electrode (ISE)
D711 Ref membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-058
In Commercial Distribution

  • 05700699420589 ()
  • 55700699420584 ()
942-058

  • Reference electrode IVD
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