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Transvalvular Insertion Tool (TVI) 00884450544105

by Merit Medical Systems, Inc.

Ref MIS-099-00/BModel Transvalvular Insertion Tool (TVI)

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Overview

A comprehensive guide to the Transvalvular Insertion Tool (TVI), a non-implantable medical device designed for percutaneous vascular access.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450544105 Basic UDI-DI 00884450544105UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450544105 UDI-DI Date28 May 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Transvalvular Insertion Tool (TVI)
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
Transvalvular Insertion Tool (TVI) EUDAMED
MIS-099-00/B EUDAMED
00884450544105 GUDID
TVI-07 GUDID
Primary DI / UDI-DI
00884450544105
Basic UDI-DI
B-00884450544105
FDA Product Code
DWS
EMDN Code
C058001 Adapters and connectors for cardiovascular introducers
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class I
Regulation Number
870.4500
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Transvalvular Insertion Tool (TVI)
MIS-099-00/B
GUDID
00884450544105

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
  • Animal Tissues
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No