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Prelude IDeal™ 10884450693237

by Merit Medical Systems, Inc.

Ref PID6F11025PW/DModel Prelude IDeal™

Prelude IDeal™ 10884450693237 (PID6F11025PW/D) is a device classified as Class IIa in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00884450693230) and listed in FDA GUDID since 26 Apr 2023 (UDI-DI 00884450693230), active as of 9 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450693230 Basic UDI-DI 00884450693230UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450693230 UDI-DI Date26 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450693230 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00884450693230 listed 26 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450693230
  2. Registered EUDAMED B-00884450693230

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Prelude IDeal™
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
Prelude IDeal™, PID6F11025PW/D, 10884450693237
Primary DI / UDI-DI
00884450693230 EUDAMED
10884450693237 GUDID
Basic UDI-DI
B-00884450693230
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Prelude IDeal™
PID6F11025PW/D
GUDID
10884450693237
Primary DI / UDI-DIEUDAMED
00884450693230
GUDID
10884450693237
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00884450693230; FDA GUDID lists 10884450693237), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular catheter introduction set, nonimplantable

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)