Quelimmune 02-1006-01

by Seastar Medical Incorporated

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberG62102100601 UDI-DI	Date21 May 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Quelimmune
Generic Name: Apheresis system column, selective leukocyte adsorption
Model / Ref / Catalog: 02-1006-01

Primary DI / UDI-DI: G62102100601
FDA Product Code: QZV
GMDN Term: Apheresis system column, selective leukocyte adsorption

Device Class: Class III
GUDID distribution status: In Commercial Distribution

Properties

Single Use
Prescription Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (8)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Serial Number: No
Manufacturing Date: No