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Fountain®

by Merit Medical Systems, Inc. 2 variants

Ref FIS5-90-50-V/AModel 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-00884450470701 Basic UDI-DI 00884450470701UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450470701 UDI-DI Date23 Feb 2024ListedStatusListed 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  • Withdrawn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

Generic name
Peripheral vascular intervention infusion catheter
Device name
Infusion Catheters and Infusion Systems
Model / Ref / Catalog
Fountain Valve Tip EUDAMED
FIS5-90-50-V/A EUDAMED
A GUDID
FIS5-90-50-V GUDID
Primary DI / UDI-DI
00884450470701
Basic UDI-DI
B-00884450470701
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
FIS5-90-50-V/A
GUDID
A
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
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (17)

  • 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
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No