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XENOVIEW Dose Delivery Bag, Carton of 50, 300 mL Rev A

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 Number00850045949129 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  • Withdrawn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
XENOVIEW Dose Delivery Bag, Carton of 50, 300 mL
Generic Name
Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
Model / Ref / Catalog
Rev A, 47471-030
Primary DI / UDI-DI
00850045949129
FDA Product Code
QVW
GMDN Term
Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
Device Class
N
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No