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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 Class Implantable

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RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1240 can determine pH, pCO2, pO2 parameters
Siemens Healthcare Diagnostics Inc.
10321840
In Commercial Distribution

  • 00630414515540 ()
5060298

  • Blood gas/haemoximetry analyser IVD, point-of-care
The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
Siemens Healthcare Diagnostics Inc.
11537817
In Commercial Distribution

  • 00630414609515 ()
11537817

  • Blood gas/haemoximetry analyser IVD, point-of-care
The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.
Siemens Healthcare Diagnostics Inc.
11416751
In Commercial Distribution

  • 00630414286143 ()
11416751

  • Blood gas/haemoximetry analyser IVD, point-of-care
Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care
Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

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

  • 00385480528573 ()
  • 10385480528570 ()
52857

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx REFERENCE TUBING REPLACEMENT, INTERNAL
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 00385480346559 ()
34655

  • Blood gas/haemoximetry analyser IVD, point-of-care
WASTE TUBE ASSEMBLY, pHOx (REPLACEMENT), INTERNAL
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 00385480346474 ()
34647

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx/BASIC/PLUS/L/C PCO2 MEMBRANE CAP KIT
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480250481 ()
  • 00385489250482 ()
25048

  • Blood gas/haemoximetry analyser IVD, point-of-care
Remanufactured Stat Profile pHOx Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 10385480239629 ()
  • 00385480239622 ()
23962

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE M/2/3 PCO2 FILLING SOLUTION
NOVA BIOMEDICAL CORPORATION
M/2/3
In Commercial Distribution

  • 00385480231237 ()
23123

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

  • 00385480219266 ()
21926

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

  • 00385480215206 ()
21520

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx PROBE
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 00385480215190 ()
21519

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx/BASIC AIR DETECTOR
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC
In Commercial Distribution

  • 00385480215138 ()
21513

  • Blood gas/haemoximetry analyser IVD, point-of-care
STAT PROFILE pHOx/BASIC/PLUS/L/C, CCX SO2 SENSOR
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480215121 ()
21512

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