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Prelude® 10884450331313

by Merit Medical Systems, Inc.

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

The Prelude device is a non-implantable vascular catheter introduction set designed for percutaneous cardiovascular access, providing a sterile and controlled environment for introductions into the vascular system. With its single-use design, this device is intended for temporary use in diagnostic or therapeutic procedures.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884450331313 UDI-DI Date25 Oct 2019ListedStatusListed 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  • Withdrawn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
10884450331313, PSI-5F-23-018NT4/C
Primary DI / UDI-DI
10884450331313
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
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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