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Na 3150-4043-6

by Gendron, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842307100065 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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

Generic Name
Bariatric bed
Model / Reference
3150-4043-6
Description
BED, ECONOMY LTC BARIATRIC LOW, S/FRAMEWIDTH EXPANDABLE; 36", 42", AND 48"84" DECK LENGTH3-FUNCTION HANDSET850 LB. CAPACITYHEAD END SIDERAILS
Primary DI / UDI-DI
00842307100065
FDA Product Code
FNL
GMDN Term
Bariatric bed
Device Class
Class II
Regulation Number
880.5100
GUDID distribution status
Not in Commercial Distribution

Other devices from Gendron, Inc.

Properties

  • Premarket Exempt
  • Serial Number

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No