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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
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G15168
In Commercial Distribution

  • 00827002151680 ()
025508

  • Polymeric ureteral stent
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G15110
In Commercial Distribution

  • 00827002151109 ()
025506

  • Polymeric ureteral stent
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G14514
In Commercial Distribution

  • 00827002145146 ()
025505

  • Polymeric ureteral stent
REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative
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