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GEN4 Plus, Direct Access 5C19DU-Z15900058

by Curbell Medical Products, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840828196239 UDI-DI Date26 Mar 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  • Withdrawn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
GEN4 Plus, Direct Access
Generic Name
Pillow speaker
Model / Ref / Catalog
5C19DU-Z15900058, 30655
Primary DI / UDI-DI
00840828196239
FDA Product Code
IQA
GMDN Term
Pillow speaker
Device Class
Class II
Regulation Number
890.3725
GUDID distribution status
In Commercial Distribution

Other devices from Curbell Medical Products, Inc

See all devices from Curbell Medical Products, Inc →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No