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Prelude Wave™ Initial Release

by Merit Medical Systems, Inc. 21 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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884450072230 UDI-DI Date26 Aug 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  • Withdrawn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 Wave™
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
Initial Release, WAV6F11025PW-F
Primary DI / UDI-DI
10884450072230
FDA product code
DYB
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

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No