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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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The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a clamp to secure XENOVIEW™ inside, and a mouthpiece for the patient to inhale the gas. XENOVIEW™ Dose Delivery Bags come packaged with 50 one-liter dose delivery bag assemblies, as well as 55 individual bag labels. The XENOVIEW™ Dose Delivery Bag is a single-dose disposable drug container, for use with the HPX Hyperpolarization System.
Polarean, Inc.
Rev B
In Commercial Distribution

  • 00850045949013 ()
44639-01

  • Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system. With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949006 ()
49820

  • Lung MRI xenon hyperpolarization system
Face Mask, Padded, Adult, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21135
In Commercial Distribution

  • 00816703025901 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Ventilation Mask Size 4
MEDSOURCE INTERNATIONAL LLC
MS-21134
In Commercial Distribution

  • 00816703025895 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Face Mask, Padded, Toddler, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21133
In Commercial Distribution

  • 00816703025888 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Face Maks, Padded, Infant, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21132
In Commercial Distribution

  • 00816703025871 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Face Mask, Padded, Neonatal, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21131
In Commercial Distribution

  • 00816703025864 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Ear-Loop Mask
MEDSOURCE INTERNATIONAL LLC
MS-12125
In Commercial Distribution

  • 00816703024713 ()
  • 00816703024720 ()
Not Applicable

  • Public face mask, reusable
Ear Loop Mask- Yellow
MEDSOURCE INTERNATIONAL LLC
MS-12126-Y
In Commercial Distribution

  • 00840155402652 ()
  • 00840155402645 ()
Not Applicable

  • Public face mask, reusable
Ear Loop Mask- Blue
MEDSOURCE INTERNATIONAL LLC
MS-12126
In Commercial Distribution

  • 00840155402621 ()
  • 00840155402638 ()
Not Applicable

  • Public face mask, reusable
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