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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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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 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
Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer
Siemens Healthcare Diagnostics Inc.
10309056
In Commercial Distribution

  • 00630414452142 ()
3372381

  • Blood gas/haemoximetry analyser IVD, point-of-care
Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems.
Siemens Healthcare Diagnostics Inc.
10317312
In Commercial Distribution

  • 00630414452074 ()
2577729

  • 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
Vivoo FSH Fertility Test (Urine), with 10 products inside.
VIVOSENS INC.
VWHF25V1
In Commercial Distribution

  • 10860011489150 ()
  • 00860011489153 ()
  • 20860011489157 ()


  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software
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
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