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Vanguard 4:1 BLOOD SET W. SHUNT

by Sorin Group Italia SRL EUDAMEDGUDID

Active European Union

Ref 050678

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8033178CARDIOPLHEXF5 Basic UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033178114486 UDI-DIDate31 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Vanguard
Generic Name
Cardioplegia solution administration kit
Device Name
Cardioplegia
Model / Reference
050678 EUDAMED
4:1 BLOOD SET W. SHUNT GUDID
Primary DI / UDI-DI
08033178114486
Basic UDI-DI
8033178CARDIOPLHEXF5
510(k) Number
FDA Product Code
DTR
EMDN Code
C030102 Cardioplegia solution administration kits
GMDN Term
Cardioplegia solution administration kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4240
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
050678
GUDID
4:1 BLOOD SET W. SHUNT
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K250150)

Other devices from Sorin Group Italia SRL

See all devices from Sorin Group Italia SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No