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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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CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 10850042559144 ()
  • 00850042559147 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution

  • 10850042559137 ()
  • 00850042559130 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 10850042559120 ()
  • 00850042559123 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 00850042559093 ()
  • 10850042559090 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution

  • 00850042559086 ()
  • 10850042559083 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 00850042559079 ()
  • 10850042559076 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Car Emergency Kit - 35 pieces
Super-Sparkly Safety Stuff, LLC
BE CEPNK
In Commercial Distribution

  • 00850042092835 ()


  • First aid kit, medicated
Car First Aid Kit - 90 Pieces
Super-Sparkly Safety Stuff, LLC
BE FAPNK
In Commercial Distribution

  • 00850042092828 ()


  • First aid kit, medicated
The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949037 ()
45660

  • Lung MRI xenon hyperpolarization system
The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
Polarean, Inc.
Rev. D
In Commercial Distribution

  • 00850045949020 ()
42881

  • Lung MRI xenon hyperpolarization system
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