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Fountain® 00884450398227

by Merit Medical Systems, Inc.

Ref IS4-135-50-VModel Fountain Valve Tip

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

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

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450398227 Basic UDI-DI 00884450398227UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450398227 UDI-DI Date1 Oct 2022ListedStatusListed 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  • Withdrawn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
Fountain®
Generic name
Peripheral vascular intervention infusion catheter
Device name
Infusion Catheters and Infusion Systems
Model / Ref / Catalog
Fountain Valve Tip, IS4-135-50-V, 00884450398227
Primary DI / UDI-DI
00884450398227
Basic UDI-DI
B-00884450398227
FDA product code
KRA
EMDN code
C0101010102 Peripheral i.v. catheters, w/o safety systems, w/o injection valves
GMDN term
Peripheral vascular intervention infusion catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1210
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Fountain Valve Tip
IS4-135-50-V
GUDID
00884450398227
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Peripheral vascular intervention infusion catheter

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
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No