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Fruit Health PI.421EGHT.O6J.2X.0.0

by Fruit of the Loom

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 Number00194422108250 UDI-DI Date19 Apr 2022ListedStatusListed 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  • Withdrawn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
Fruit Health
Generic Name
Isolation gown, single-use
Model / Reference
PI.421EGHT.O6J.2X.0.0
Primary DI / UDI-DI
00194422108250
FDA Product Code
OEA
GMDN Term
Isolation gown, single-use
Device Class
Class I
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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