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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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
D513 Disposable waste container 600mL, for ABL8XX FLEX
Radiometer Medical ApS
905-802
In Commercial Distribution

  • 05700699058027 ()
905-802

  • Laboratory waste receptacle IVD
ABL800 FLEX with crea
Radiometer Medical ApS
393-801
In Commercial Distribution

  • 05700693938011 ()
393-801

  • Multiple clinical chemistry analyser IVD, laboratory
ABL800 FLEX
Radiometer Medical ApS
393-800
In Commercial Distribution

  • 05700693938004 ()
393-800

  • Multiple clinical chemistry analyser IVD, laboratory
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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