FLUME catheter Kit 16Fr

by The Flume Catheter Company Limited

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	Number05060894850049 UDI-DI	Date14 Nov 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: FLUME catheter
Generic Name: Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog: FLUME catheter Kit 16Fr, 1006

Primary DI / UDI-DI: 05060894850049
FDA Product Code: EZL, KOB
GMDN Term: Indwelling urethral drainage balloon catheter, non-antimicrobial

Device Class: Class II
Regulation Number: 876.5130, 876.5090
GUDID distribution status: In Commercial Distribution

Other devices from The Flume Catheter Company Limited

Properties

Sterile
Single Use
Prescription Use
Convenience Kit
Lot / Batch Number
Expiration Date

Other properties (8)

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