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Surity Urinary Management System with Battery 3800340

by Wellspect AB

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07333387059198 UDI-DI Date18 Aug 2026ListedStatusListed 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  • Withdrawn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
Surity Urinary Management System with Battery
Generic Name
Bed incontinence system
Model / Ref / Catalog
3800340
Description
1 Suction Base with battery, 1 Instructions for Use, 1 Collection canister & lid, 1 Suction tubing, 1 Elbow connector, 1 Power adapter, 4 Carbon filters
Primary DI / UDI-DI
07333387059198
FDA Product Code
NZU
GMDN Term
Bed incontinence system
Device Class
Class I
Regulation Number
876.5250
GUDID distribution status
In Commercial Distribution

Other devices from Wellspect AB

See all devices from Wellspect AB →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No