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Protexter 1

by Icp Medical, LLC 11 variants

Protexter 1 (ICP-8400FC) is a Class I device made by Icp Medical, LLC, listed in FDA GUDID since 10 Jul 2025 (UDI-DI 00688162000597), 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 Number00688162000597 UDI-DI Date10 Jul 2025ListedStatusListed 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  • Withdrawn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
Protexter
Generic name
Isolation gown, single-use
Model / Ref / Catalog
1, ICP-8400FC
Primary DI / UDI-DI
00688162000597
FDA product code
OEA
GMDN term
Isolation gown, single-use
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isolation gown, single-use

Other devices from Icp Medical, LLC

See all devices from Icp Medical, LLC →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)