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Y-Cbl CO2 and Analog/Sync MS22259

by Draeger Medical Systems, Inc.

Ref MS22259Model 307028XK19Z000

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number040486752307028XK19Z000JP Basic UDI-DI 04049098054416UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098054416 UDI-DI Date2 Nov 2015ListedStatusListed 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.

Recalls

8 recalls · 2 ongoing · FDA

    • Ongoing Z-1104-2021 FDA Class II initiated 23 Dec 2020

    The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.

    • Ongoing Z-0258-2020 FDA Class II initiated 13 Sep 2019

    Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

    • Terminated Z-1813-2018 FDA Class II initiated 28 Mar 2018

    Software anomaly resulting in the loss of patient settings and stored patient data.

    • Terminated Z-1382-2018 FDA Class II initiated 21 Feb 2018

    The invasive pressure visual and audible alarms may not activate.

    • Terminated Z-0942-2018 FDA Class II initiated 4 Oct 2017

    Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.

    • Terminated Z-2734-2017 FDA Class II initiated 6 Jun 2017

    Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

    • Terminated Z-0714-2014 FDA Class II initiated 10 Dec 2013

    After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.

    • Terminated Z-0939-2013 FDA Class II initiated 13 Dec 2012

    The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade Name
Y-Kabel CO2 and Analog/Sync EUDAMED
Y-Cbl CO2 and Analog/Sync GUDID
Generic Name
Electrical-only medical device connection cable, reusable
Model / Reference
MS22259, 307028XK19Z000
Primary DI / UDI-DI
04049098054416
Basic UDI-DI
040486752307028XK19Z000JP
510(k) Number
FDA Product Code
MSX, MHX
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2300, 870.1025
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K113798)

Show all (12)

Other devices from Draeger Medical Systems, Inc.

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Properties

  • Manufacturing Date

Other properties (23)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No