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Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE 2105488-004

by Flexicare Medical Limited

Ref 2105488-004

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788776901 Basic UDI-DI 05055788776901UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788776901 UDI-DI Date18 Jun 2020ListedStatusListed 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  • Withdrawn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
Flexicare EUDAMED
Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE GUDID
Generic Name
Straight/elbow breathing circuit connector, reusable
Device Name
Breathing System Components and Accessories
Model / Reference
2105488-004
Primary DI / UDI-DI
05055788776901
Basic UDI-DI
B-05055788776901
FDA Product Code
BZA
EMDN Code
R028099 Respiratory circuits and mount catheters - accessories not included in other classes
GMDN Term
Straight/elbow breathing circuit connector, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5810
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Straight/elbow breathing circuit connector, reusable

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No