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Prevena Plus™ PRE4001US

by Kci USA, Inc.

Prevena Plus™ PRE4001US is a Class II device made by Kci USA, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00849554005358), 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 Number00849554005358 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
Prevena Plus™
Generic name
Negative-pressure wound therapy system, electric, single-use
Model / reference
PRE4001US
Primary DI / UDI-DI
00849554005358
FDA product code
OMP
GMDN term
Negative-pressure wound therapy system, electric, single-use
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Negative-pressure wound therapy system, electric, single-use

Similar devices in this category

Other devices filed under Negative-pressure wound therapy system, electric, single-use.

Other devices from Kci USA, Inc.

See all devices from Kci USA, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)