HPX Polarization Measurement Station Rev. D

by Polarean, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850045949020 UDI-DI	Date4 May 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: HPX Polarization Measurement Station
Generic Name: Lung MRI xenon hyperpolarization system
Model / Ref / Catalog: Rev. D, 42881

Primary DI / UDI-DI: 00850045949020
FDA Product Code: QVW
GMDN Term: Lung MRI xenon hyperpolarization system

Device Class: N
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Combination Product
Serial Number

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No
Manufacturing Date: No