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Universal Vented Vial Access Device

by Yukon Medical, LLC

Ref YM005

Universal Vented Vial Access Device (YM005) is a vial/bottle adaptor (EU MDD Class I; FDA Class II; FDA product code LHI, Set, I.V. Fluid Transfer) made by Yukon Medical, LLC, registered in EUDAMED on 20 Apr 2023 (Basic UDI-DI B-00851891007100) and listed in FDA GUDID since 12 Jun 2017 (UDI-DI 00851891007100), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00851891007100 Basic UDI-DI 00851891007100UDI-DIDate20 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00851891007100 UDI-DI Date12 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00851891007100 registered 20 Apr 2023 Active
  • FDA GUDID UDI-DI 00851891007100 listed 12 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00851891007100
  2. Registered EUDAMED B-00851891007100

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  • Withdrawn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
Vial/bottle adaptor, non-hermetic
Device name
Vented Single Vial Access Device
Model / Ref / Catalog
YM005
Primary DI / UDI-DI
00851891007100
Basic UDI-DI
B-00851891007100
FDA product code
LHI
EMDN code
A070199 Adapters and connectors - other
GMDN term
Vial/bottle adaptor, non-hermetic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5440
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000027131
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

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Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)