XENOVIEW Dose Delivery Bag, Carton of 50, 750 mL

Primary DI
00850045949105
Brand
XENOVIEW Dose Delivery Bag, Carton of 50, 750 mL
Company
Polarean, Inc.
Model
Rev A
Catalog number
47471-075
Device description
The XENOVIEW® Dose Delivery Bag is a single-use disposable drug container, for use with the HPX 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 mouthpiece for easy administration to the patient. The 47471-075 XENOVIEW® Dose Delivery Bag Carton comes packaged with 50 each of 750 mL Dose Delivery Bag assemblies, as well as 55 individual bag labels.
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00850045949105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045949105008500459491058500459491050850045949105

GMDN Terms#

Term, Definition table
TermDefinition
Lung MRI xenon hyperpolarization system delivery bag/mouthpieceA synthetic polymer reservoir sac with an attached mouthpiece intended to temporarily store hyperpolarized Xenon (Xe) for subsequent patient inhalation to improve lung magnetic resonance imaging (MRI). A lung MRI xenon hyperpolarization system is used to accurately fill a known amount of hyperpolarized Xe into the bag, which is subsequently transported to the patient in the MRI suite for inhalation using the attached mouthpiece. This is a single-use device.

Regulatory Flags#

DUNS number
078629330
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
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
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
00850045949037HPX Gas Handling ManifoldRev E456602023-05-04

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
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
00850045949037HPX Gas Handling ManifoldPolarean, Inc.QVW2023-05-04