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Marpac Inc 400

by Marpac, Inc.

Marpac Inc 400 is a Class I device made by Marpac, Inc., listed in FDA GUDID since 3 Apr 2023 (UDI-DI 00653658004007), 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 Number00653658004007 UDI-DI Date3 Apr 2023ListedStatusListed 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  • Withdrawn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
Marpac Inc
Generic name
Urinary catheter holder, single-use
Model / reference
400
Primary DI / UDI-DI
00653658004007
FDA product code
KGZ
GMDN term
Urinary catheter holder, single-use
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urinary catheter holder

Similar devices

Other devices filed under FDA product code KGZ (Accessories, Catheter).

Other devices from Marpac, Inc.

See all devices from Marpac, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)