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/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
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
Sensor cassette SC90 1200 BG, LYT, MET, OXI + QC for ABL90. 1200 tests. Blood gas, Electrolytes, Metabolites, CO-OX including Auto QC
Radiometer Medical ApS
946-060
In Commercial Distribution

  • 05700699460608 ()
946-060

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
SC90 50 BG, LYT, MET, OXI + QC
Radiometer Medical ApS
946-050
In Commercial Distribution

  • 05700699460509 ()
946-050

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Sensor cassette SC90 600 BG, LYT, OXI + QC for ABL90, 600 tests. Blood gas, Electrolytes, CO-OX. Including Auto QC
Radiometer Medical ApS
946-013
In Commercial Distribution

  • 05700699460134 ()
946-013

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Sensor cassette SC90 100 BG, LYT, MET, OXI +QC Blood gas, lytes, metabolites, CO-OX including auto QC.
Radiometer Medical ApS
946-010
In Commercial Distribution

  • 05700699460103 ()
946-010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Sensor cassette SC90 900 BG, LYT, MET, OXI + QC for ABL90. 900 tests. Blood gas, Electrolytes , Metabolites, CO-OX including Auto QC.
Radiometer Medical ApS
946-009
In Commercial Distribution

  • 05700699460097 ()
946-009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Sensor cassette SC90 600 BG, LYT, MET, OXI + QC for ABL90. 600 tests. Blood gas, Electrolytes, Metabolites, CO-OX, Including Auto QC
Radiometer Medical ApS
946-008
In Commercial Distribution

  • 05700699460080 ()
946-008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Electrolytes, Metabolites, CO-OX, Including Auto QC
Radiometer Medical ApS
946-005
In Commercial Distribution

  • 05700699460059 ()
946-005

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Solution pack XL for ABL90 FLEX and ABL90 FLEX PLUS
Radiometer Medical ApS
944-457
In Commercial Distribution

  • 05700699444578 ()
944-457

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
ABL90 FLEX Solution pack
Radiometer Medical ApS
944-157
In Commercial Distribution

  • 05700699441577 ()
944-157

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
ABL90 FLEX Inlet Clip to attach to ABL90 inlet
Radiometer Medical ApS
925-047
In Commercial Distribution

  • 05700699250476 ()
925-047

  • Metabolic profile clinical chemistry analyser IVD
ABL90 FLEX, Clot catcher, box of 250 pcs.
Radiometer Medical ApS
906-026
In Commercial Distribution

  • 05700699060266 ()
  • 55700699060261 ()
906-026

  • Analyser blood clot protection filter IVD
Solution box for ABL90FLEX PLUS SBOX PLUS
Radiometer Medical ApS
905-956
Not in Commercial Distribution

  • 05700699059567 ()
905-956

  • Metabolic profile clinical chemistry analyser IVD
Flush device for ABL90 FLEX
Radiometer Medical ApS
905-918
In Commercial Distribution

  • 05700699059185 ()
905-918

  • Metabolic profile clinical chemistry analyser IVD
Solution box for the ABL90 FLEX, SBOX
Radiometer Medical ApS
905-917
Not in Commercial Distribution

  • 05700699059178 ()
905-917

  • Metabolic profile clinical chemistry analyser IVD
ABL90 FLEX PLUS, Analyzer without casettes, cables, manuals etc.
Radiometer Medical ApS
393-092
In Commercial Distribution

  • 05700693930923 ()
393-092

  • Metabolic profile clinical chemistry analyser IVD
ABL90 FLEX, Analyzer without casettes, cables, manuals etc.
Radiometer Medical ApS
393-090
In Commercial Distribution

  • 05700693930909 ()
393-090

  • Metabolic profile clinical chemistry analyser IVD
STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 115 uL WITH Na HEPARIN
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480407298 ()
  • 00385489407299 ()
40729

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
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