AccessGUDID - DEVICE: XENOVIEW Dose Delivery Bag (00850045949013)

GUDID

Device Identifier (DI) Information

Brand Name: XENOVIEW Dose Delivery Bag
Version or Model: Rev B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44639-01
Company Name: Polarean, Inc.

Primary DI Number: 00850045949013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078629330 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66746	Lung MRI xenon hyperpolarization system delivery bag/mouthpiece	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVW	Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71162bfb-7245-4220-a8ea-a385a0c85cae
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023