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Prelude® 10884450122706

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 single-use, non-implantable vascular catheter introduction set designed for percutaneous vascular access. It features a non-steerable introducer sheath with an inner obturator/dilator and additional access devices such as guidewires, introducer needles, syringes, and haemostatic valves. The device is intended for use in cardiovascular procedures, specifically to introduce catheters into the vascular system. The Prelude has undergone rigorous testing and meets FDA clearance requirements.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884450122706 UDI-DI Date4 Dec 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  • Withdrawn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 / Reference
10884450122706
Primary DI / UDI-DI
10884450122706
FDA Product Code
OEX
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
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
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

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