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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S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Radiometer Medical ApS
944-136
In Commercial Distribution

  • 15700699441369 ()
  • 05700699441362 ()
944-136

  • Wash/cleaning solution IVD, automated/semi-automated system
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
Radiometer Medical ApS
944-135
In Commercial Distribution

  • 15700699441352 ()
  • 05700699441355 ()
944-135

  • Multiple blood gas analyte IVD, calibrator
S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Radiometer Medical ApS
944-134
In Commercial Distribution

  • 15700699441345 ()
  • 05700699441348 ()
944-134

  • Multiple blood gas analyte IVD, calibrator
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
Radiometer Medical ApS
944-133
In Commercial Distribution

  • 15700699441338 ()
  • 05700699441331 ()
944-133

  • Multiple blood gas analyte IVD, calibrator
S4980 Rinse Solution 600mL, for ABL800 FLEX
Radiometer Medical ApS
944-130
In Commercial Distribution

  • 05700699441300 ()
944-130

  • Wash/cleaning solution IVD, automated/semi-automated system
S1830 Calibration Solution 2, 200 mL, for ABL800 FLEX
Radiometer Medical ApS
944-129
In Commercial Distribution

  • 05700699441294 ()
944-129

  • Multiple blood gas analyte IVD, calibrator
S1820 Calibration Solution 1, 200 mL, for ABL800 FLEX
Radiometer Medical ApS
944-128
In Commercial Distribution

  • 05700699441287 ()
944-128

  • Multiple blood gas analyte IVD, calibrator
S1820 Calibration Solution 1, 200 mL, for ABL800 FLEX
Radiometer Medical ApS
944-127
In Commercial Distribution

  • 05700699441270 ()
944-127

  • Multiple blood gas analyte IVD, calibrator
S8375 Cleaning Solution 175mL for ABL8XX
Radiometer Medical ApS
944-126
In Commercial Distribution

  • 05700699441263 ()
944-126

  • Wash/cleaning solution IVD, automated/semi-automated system
S5362 Hypochlorit Solution for protein Removal and decontamination 100mL for BPH5, ABL5/50/5XX, EML10X ABL8XX
Radiometer Medical ApS
943-906
In Commercial Distribution

  • 05700699439062 ()
943-906

  • Wash/cleaning solution IVD, automated/semi-automated system
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution

  • 05700699420732 ()
942-073

  • 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
D799 pO2 membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-064
In Commercial Distribution

  • 05700699420640 ()
  • 55700699420645 ()
942-064

  • Blood gas pO2 IVD, kit, ion-selective electrode (ISE)
D788 pCO2 membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-063
In Commercial Distribution

  • 05700699420633 ()
  • 55700699420638 ()
942-063

  • Blood gas pCO2 IVD, kit, ion-selective electrode (ISE)
D755 Na membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-062
In Commercial Distribution

  • 05700699420626 ()
  • 55700699420621 ()
942-062

  • Sodium (Na+) IVD, kit, ion-selective electrode (ISE)
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)
Accessories starter kit for ABL800 FLEX
Radiometer Medical ApS
905-834
Not in Commercial Distribution

  • 05700699058348 ()
905-834

  • Transcutaneous blood gas monitor sensor
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