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GEN4 Direct Access 4C370U-P003BFB

by Curbell Medical Products, Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number00840828164443 UDI-DI Date13 Nov 2018ListedStatusListed GUDID: not 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  • Withdrawn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 Direct Access
Generic Name
Pillow speaker
Model / Ref / Catalog
4C370U-P003BFB, 1975
Primary DI / UDI-DI
00840828164443
FDA Product Code
ILQ
GMDN Term
Pillow speaker
Device Class
Class II
Regulation Number
890.3710
GUDID distribution status
Not 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