FDA.reportPublic FDA data

HPX Gas Handling Manifold

Primary DI
00850045949037
Brand
HPX Gas Handling Manifold
Company
Polarean, Inc.
Model
Rev E
Catalog number
45660
Device description
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.
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QVWGenerator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVWGenerator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-LedUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045949037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045949037008500459490378500459490370850045949037

GMDN Terms#

Term, Definition table
TermDefinition
Lung MRI xenon hyperpolarization systemAn electrically-powered assembly of devices designed for the production and measurement of hyperpolarized xenon (Xe) gas delivered to the lungs to improve lung magnetic resonance imaging (MRI) during assessment of lung function. It consists of a hyperpolarized xenon generator, a measurement station, and gas delivery equipment. The system includes a wide variety of technologies such as laser-based hyperpolarization, magnetic field generation to slow relaxation of hyperpolarized Xe, and nuclear magnetic resonance (NMR) based measurement of hyperpolarized Xe; it is used with a disposable delivery bag for measured dosing of hyperpolarized Xe to the patient via a mask/mouthpiece.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078629330
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045949136XENOVIEW VDP1.2.2357902026-05-07
00850045949075XENOVIEW 3.0T Chest Coil-GE PremierRev A44315-042025-12-19
00850045949082HPX Polarization Measurement StationRev. E428812025-10-13
00850045949099XENOVIEW Dose Delivery Bag, Carton of 50, 1,000 mLRev A47471-1002025-10-13
00850045949105XENOVIEW Dose Delivery Bag, Carton of 50, 750 mLRev A47471-0752025-10-13
00850045949112XENOVIEW Dose Delivery Bag, Carton of 50, 500 mLRev A47471-0502025-10-13
00850045949129XENOVIEW Dose Delivery Bag, Carton of 50, 300 mLRev A47471-0302025-10-13
00850045949044XENOVIEW 3.0T Chest CoilRev C44315-012025-09-23
00850045949051XENOVIEW 3.0T Chest CoilRev B44315-032025-09-23
00850045949006HPX HyperpolarizerRev E498202023-05-04
00850045949013XENOVIEW Dose Delivery BagRev B44639-012023-05-04
00850045949020HPX Polarization Measurement StationRev. D428812023-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045949082HPX Polarization Measurement StationPolarean, Inc.QVW2025-10-13
00850045949099XENOVIEW Dose Delivery Bag, Carton of 50, 1,000 mLPolarean, Inc.QVW2025-10-13
00850045949105XENOVIEW Dose Delivery Bag, Carton of 50, 750 mLPolarean, Inc.QVW2025-10-13
00850045949112XENOVIEW Dose Delivery Bag, Carton of 50, 500 mLPolarean, Inc.QVW2025-10-13
00850045949129XENOVIEW Dose Delivery Bag, Carton of 50, 300 mLPolarean, Inc.QVW2025-10-13
00850045949006HPX HyperpolarizerPolarean, Inc.QVW2023-05-04
00850045949013XENOVIEW Dose Delivery BagPolarean, Inc.QVW2023-05-04
00850045949020HPX Polarization Measurement StationPolarean, Inc.QVW2023-05-04