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Prelude® F

by Merit Medical Systems, Inc. 65 variants

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Overview

Prelude vascular catheter introduction set is a single-use, non-implantable device designed for percutaneous vascular access. It provides a collection of non-invasive devices intended to enable introduction of a catheter into the vascular system.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884450706166 UDI-DI Date17 May 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prelude®
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
F, PSI-4F-11
Primary DI / UDI-DI
10884450706166
FDA Product Code
DRE
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No