AccessGUDID - DEVICE: HPX Polarization Measurement Station (00850045949020)

GUDID

Device Identifier (DI) Information

Brand Name: HPX Polarization Measurement Station
Version or Model: Rev. D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42881
Company Name: Polarean, Inc.

Primary DI Number: 00850045949020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078629330 *Terms of Use

Device Description: The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.

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:	No
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?
66745	Lung MRI xenon hyperpolarization system	An 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.	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: 861eabf8-e373-49a3-a0e7-eda0d2f94c11
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023