XENOVIEW Dose Delivery Bag Rev B

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	Number00850045949013 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Withdrawn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: XENOVIEW Dose Delivery Bag
Generic Name: Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
Model / Ref / Catalog: Rev B, 44639-01

Primary DI / UDI-DI: 00850045949013
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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Not classified
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Not classified
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Not classified

See all devices from Polarean, Inc. →

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