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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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No Description
HF ACQUISITION CO. LLC
1006580
In Commercial Distribution

  • 00850065007137 ()
1006580

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1006570
In Commercial Distribution

  • 00850065007120 ()
1006570

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1003470
In Commercial Distribution

  • 00850065007038 ()
1003470

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1003440
In Commercial Distribution

  • 00850065007021 ()
1003440

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1003430
In Commercial Distribution

  • 00850065007014 ()
1003430

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1003420
In Commercial Distribution

  • 00850065007007 ()
1003420

  • First aid kit, medicated
Qty 2 NALOXONE HCL Nasal Spray 4mg/dose. Manufactured by Padagis, Qty 1 CPR Face Shield and a carry case.
INTEGRATED MEDCRAFT LLC
1011-46000
In Commercial Distribution

  • 00850056748193 ()


  • 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
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
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