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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Prime Sensor Card CCS Comp (High Volume)
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480552643 ()
  • 00385480552646 ()
55264

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Sensor Card CCS (High Volume)
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480552636 ()
  • 00385480552639 ()
55263

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Prime CCS Comp w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480536677 ()
  • 10385480536674 ()
53667

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime CCS w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CSS
In Commercial Distribution

  • 00385480536561 ()
  • 10385480536568 ()
53656

  • Blood gas analyser IVD, point-of-care
Remanufactured PRIME CCS Comp Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480534208 ()
  • 10385480534205 ()
53420

  • Blood gas/haemoximetry analyser IVD, point-of-care
Remanufacture PRIME CCS Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480534185 ()
  • 10385480534182 ()
53418

  • Co-oximetry analyser IVD, point-of-care
Stat Profile Prime Calibrator Flush Fixture
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480528658 ()
52865

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime CCS Comp Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480528573 ()
  • 10385480528570 ()
52857

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime CCS Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480528566 ()
  • 10385480528563 ()
52856

  • Blood gas analyser IVD, point-of-care
Prime Safety Sample Port 5 Pk
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480526692 ()
  • 00385489526693 ()
52669

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Tubing L1 L2 L3
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480526166 ()
52616

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Probe S Line 100 ul
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480525824 ()
52582

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Reference Cartridge
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480420433 ()
42043

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Prime Sensor Card CCS Comp
NOVA BIOMEDICAL CORPORATION
Prime CCS Comp
In Commercial Distribution

  • 10385480420331 ()
  • 00385480420334 ()
42033

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Sensor Card CCS
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480420324 ()
  • 00385480420327 ()
42032

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Prime CCS w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480536660 ()
  • 10385480536667 ()
53666

  • Blood gas analyser IVD, point-of-care
Prime CCS Comp w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480536578 ()
  • 10385480536575 ()
53657

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime Tubing L1 L2 L3
NOVA BIOMEDICAL CORPORATION
Prime ABG/CCS
In Commercial Distribution

  • 00385480526173 ()
52617

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Pump Harness
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524841 ()
52484

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445011
In Commercial Distribution

  • 08426950807827 ()
00055445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430011
In Commercial Distribution

  • 08426950807766 ()
00055430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415011
In Commercial Distribution

  • 08426950807704 ()
00055415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407511
In Commercial Distribution

  • 08426950807643 ()
00055407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360011
In Commercial Distribution

  • 08426950807605 ()
00055360011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
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
Remanufactured Stat Profile pHOx Plus L Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 10385480347171 ()
  • 00385480347174 ()
34717

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Plus L Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 10385480340813 ()
  • 00385480340816 ()
34081

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Plus/L/C/M W/R Tubing Set
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/L/C/M
In Commercial Distribution

  • 00385480329651 ()
32965

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE pHOx PLUS/L/C/M W/R Pump Tubing Assembly
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480230230 ()
23023

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480225076 ()
22507

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx/BASIC/PLUS/L/C REFERENCE LINE ASSEMBLY
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480214971 ()
21497

  • Blood gas/haemoximetry analyser IVD, point-of-care
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
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