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A Plus 1

by A Plus International, Inc 259 variants

A Plus 1 (68-561W-X) is a Class I device made by A Plus International, Inc, listed in FDA GUDID since 17 Nov 2022 (UDI-DI 00683534060131), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00683534060131 UDI-DI Date17 Nov 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  • Withdrawn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
A Plus
Generic name
Isolation gown, single-use
Model / Ref / Catalog
1, 68-561W-X
Primary DI / UDI-DI
00683534060131
FDA product code
LYU
GMDN term
Isolation gown, single-use
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LYU (Accessory, Surgical Apparel).

Other devices from A Plus International, Inc

See all devices from A Plus International, Inc →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)