HPX Hyperpolarizer 49820

GUDID 00850045949006

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.

Lung MRI xenon hyperpolarization system

• Primary Device ID: 00850045949006
• NIH Device Record Key: 9b32f9a1-aa80-4218-b4a0-f3a3ad7a0fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HPX Hyperpolarizer
• Version Model Number: Rev E
• Catalog Number: 49820
• Company DUNS: 078629330
• Company Name: Polarean, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045949006 [Primary]

FDA Product Code

• QVW: Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by Polarean, Inc.

• 00850045949006 - HPX Hyperpolarizer: 2023-05-12The 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™.
• 00850045949006 - HPX Hyperpolarizer: 2023-05-12 The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It cons
• 00850045949013 - XENOVIEW Dose Delivery Bag: 2023-05-12 The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperp
• 00850045949020 - HPX Polarization Measurement Station: 2023-05-12 The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 1
• 00850045949037 - HPX Gas Handling Manifold: 2023-05-12 The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two