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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 Size Device Size Type Device Class Implantable

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Stat Profile pHOx Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 10385480214909 ()
  • 00385480214902 ()
21490

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime Sensor Card CCS Comp 100
NOVA BIOMEDICAL CORPORATION
Prime
In Commercial Distribution

  • 10385480642511 ()
  • 00385480642514 ()
64251

  • 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
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
RAPIDLab® 1200 Series CO-ox Sample Chamber for in vitro diagnostics use.
Siemens Healthcare Diagnostics Inc.
10324165
In Commercial Distribution

  • 00630414492629 ()
6324604

  • 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
CB Menopause Stage Indicator 5ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Menopause Stage Indicator
In Commercial Distribution

  • 10633472602242 ()
  • 00633472602245 ()
  • 00633472000577 ()
N/A

  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
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