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Allcare EF800

by Allcare, Inc.

Allcare EF800 is a basic bed sheet (FDA Class I; FDA product code KME, Bedding, Disposable, Medical) made by Allcare, Inc., listed in FDA GUDID since 12 Jul 2022 (UDI-DI 10182921000691), 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 Number10182921000691 UDI-DI Date12 Jul 2022ListedStatusListed 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  • Withdrawn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
Allcare
Generic name
Basic bed sheet, single-use
Model / Ref / Catalog
EF800
Description
DISPOSABLE HEAVY DUTY FITTED SHEET 30" X 72" WHITE
Primary DI / UDI-DI
10182921000691
FDA product code
KME
GMDN term
Basic bed sheet, single-use
Device class
Class I
Regulation number
880.6060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic bed sheet, single-use

Similar devices

Other devices filed under FDA product code KME (Bedding, Disposable, Medical).

Other devices from Allcare, Inc.

See all devices from Allcare, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)