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 Class Implantable

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STAT PROFILE PREHEATER CLEANING AGENT
NOVA BIOMEDICAL CORPORATION
1
In Commercial Distribution

  • 00385480118026 ()
11802

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE pHOx/BASIC/PLUS/L/C FLUSH FIXTURE
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480243278 ()
24327

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN
NOVA BIOMEDICAL CORPORATION
ULTRA
In Commercial Distribution

  • 00385480115339 ()
  • 00385489115330 ()
11533

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Calibration gas 2, 10bar on-board gas bottle for USA and Canada
Radiometer Medical ApS
962-175
In Commercial Distribution

  • 05700699621757 ()
962-175

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Calibration gas 1, 34bar on-board gas bottle for USA and Canada
Radiometer Medical ApS
962-174
In Commercial Distribution

  • 05700699621740 ()
962-174

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Calibration gas 2, 10bar on-board gas bottle
Radiometer Medical ApS
962-170
Not in Commercial Distribution

  • 05700699621702 ()
962-170

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Calibration gas 1, 10bar on-board gas bottle
Radiometer Medical ApS
962-169
Not in Commercial Distribution

  • 05700699621696 ()
962-169

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
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
E7066 Glucose electrode for ABL7XX/8XX
Radiometer Medical ApS
945-620
In Commercial Distribution

  • 05700699456205 ()
945-620

  • Glucose IVD, kit, electrometry
E7077 Lactate electrode for ABL7XX/8XX
Radiometer Medical ApS
945-619
In Commercial Distribution

  • 05700699456199 ()
945-619

  • Lactate electrode IVD
E755 Na electrode for ABL7XX/8XX
Radiometer Medical ApS
945-618
In Commercial Distribution

  • 05700699456182 ()
945-618

  • Sodium (Na+) IVD, kit, ion-selective electrode (ISE)
E744 Cl electrode for ABL7XX/8XX
Radiometer Medical ApS
945-617
In Commercial Distribution

  • 05700699456175 ()
945-617

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
E733 Ca electrode for ABL7XX/8XX
Radiometer Medical ApS
945-616
In Commercial Distribution

  • 05700699456168 ()
945-616

  • Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)
E722 K electrode for ABL7XX/8XX
Radiometer Medical ApS
945-615
In Commercial Distribution

  • 05700699456151 ()
945-615

  • Potassium (K+) IVD, kit, ion-selective electrode (ISE)
E777 pH electrode for ABL7XX/8XX
Radiometer Medical ApS
945-614
In Commercial Distribution

  • 05700699456144 ()
945-614

  • Blood gas pH IVD, kit, ion-selective electrode (ISE)
E799 pO2 Electrode for ABL7XX/8XX
Radiometer Medical ApS
945-613
In Commercial Distribution

  • 05700699456137 ()
945-613

  • Blood gas pO2 IVD, kit, ion-selective electrode (ISE)
E788 pCO2 electrode for ABL7XX/8XX
Radiometer Medical ApS
945-612
In Commercial Distribution

  • 05700699456120 ()
945-612

  • Blood gas pCO2 IVD, kit, ion-selective electrode (ISE)
E1001 Reference electrode for ABL7XX/8XX
Radiometer Medical ApS
945-603
In Commercial Distribution

  • 05700699456038 ()
945-603

  • Reference electrode IVD
S4987 Crea Rinse Solution II 600mL for ABL8XX, USA
Radiometer Medical ApS
944-155
In Commercial Distribution

  • 05700699441553 ()
944-155

  • Wash/cleaning solution IVD, automated/semi-automated system
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