Skip to content

Dlp® 10005OS

by Medtronic, Inc.

Ref 10005OS

Dlp 10005OS is a cardioplegia solution administration adaptor (EU MDD Class IIa; FDA Class II; FDA product code DTL, Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass) made by Medtronic, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-20613994736653) and listed in FDA GUDID since 22 May 2016 (UDI-DI 20613994736653), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20613994736653 Basic UDI-DI 20613994736653UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20613994736653 UDI-DI Date22 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-20613994736653 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 20613994736653 listed 22 May 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20613994736653
  2. Registered EUDAMED B-20613994736653

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  • Withdrawn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
Dlp®
Generic name
Cardioplegia solution administration adaptor
Device name
DLP “Y” Adapter
Model / reference
10005OS
Primary DI / UDI-DI
20613994736653
Basic UDI-DI
B-20613994736653
FDA product code
DTL
EMDN code
C0301040499 Cardioplegia cannulas - other
GMDN term
Cardioplegia solution administration adaptor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4290
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Cardioplegia solution administration adaptor

Similar devices in this category

Other devices filed under EXTRACORPOREAL CIRCULATION CANNULAS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)