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HPX Polarization Measurement Station Rev. E

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850045949082 UDI-DI Date13 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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. E, 42881
Primary DI / UDI-DI
00850045949082
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