XENOVIEW Dose Delivery Bag 44639-01

GUDID 00850045949013

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.

Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
Primary Device ID00850045949013
NIH Device Record Key71162bfb-7245-4220-a8ea-a385a0c85cae
Commercial Distribution StatusIn Commercial Distribution
Brand NameXENOVIEW Dose Delivery Bag
Version Model NumberRev B
Catalog Number44639-01
Company DUNS078629330
Company NamePolarean, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045949013 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-12
Device Publish Date2023-05-04

Devices Manufactured by Polarean, Inc.

00850045949006 - HPX Hyperpolarizer2023-05-12 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 Bag2023-05-12The 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.
00850045949013 - XENOVIEW Dose Delivery Bag2023-05-12 The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperp
00850045949020 - HPX Polarization Measurement Station2023-05-12 The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 1
00850045949037 - HPX Gas Handling Manifold2023-05-12 The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two

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