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Responder 5, Enhanced 4C410U-100003A

by Curbell Medical Products, Inc

Responder 5, Enhanced 4C410U-100003A (2048) is a Class II device made by Curbell Medical Products, Inc, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00840828108294), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840828108294 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Responder 5, Enhanced
Generic name
Pillow speaker
Model / Ref / Catalog
4C410U-100003A, 2048
Primary DI / UDI-DI
00840828108294
FDA product code
ILQ
GMDN term
Pillow speaker
Device class
Class II
Regulation number
890.3710
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pillow speaker

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 (11, all answered No)