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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S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system
S1720 Calibration Solution 1 200 mL, for ABL7XX.
Radiometer Medical ApS
944-064
Not in Commercial Distribution

  • 05700699440648 ()
944-064

  • Multiple blood gas analyte IVD, calibrator
Rinse Solution S4970 REF 944-057 600mL
Radiometer Medical ApS
944-057
In Commercial Distribution

  • 05700699440570 ()
944-057

  • Wash/cleaning solution IVD, automated/semi-automated system
S1730 Calibration Solution 2 200 mL, for ABL7XX
Radiometer Medical ApS
944-025
Not in Commercial Distribution

  • 05700699440259 ()
944-025

  • Multiple blood gas analyte IVD, calibrator
S1720 Calibration Solution 1 200 mL, for ABL7XX
Radiometer Medical ApS
944-024
Not in Commercial Distribution

  • 05700699440242 ()
944-024

  • Multiple blood gas analyte IVD, calibrator
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
Radiometer Medical ApS
944-021
In Commercial Distribution

  • 05700699440211 ()
  • 55700699440216 ()
944-021

  • Multiple blood gas analyte IVD, calibrator
D711 Ref membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-058
In Commercial Distribution

  • 05700699420589 ()
  • 55700699420584 ()
942-058

  • Reference electrode IVD
Clot catcher, box of 250 pcs. for ABL7XX
Radiometer Medical ApS
906-020
In Commercial Distribution

  • 05700699060204 ()
  • 55700699060209 ()
906-020

  • Analyser blood clot protection filter IVD
D512 Disposable waste container 600mL for ABL7XX
Radiometer Medical ApS
905-590
Not in Commercial Distribution

  • 05700699055903 ()
905-590

  • Laboratory waste receptacle IVD
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0037
In Commercial Distribution

  • EABA40000371 ()
  • EABA40000370 ()
400-0037

  • Lactate IVD, reagent
  • Magnesium (Mg2+) IVD, reagent
  • Inorganic phosphate (PO43-) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Albumin IVD, reagent
  • Glucose IVD, reagent
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