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Vital Signs™ Cardiac output in-line injectate probe for GE monitors, ICU Medical Thermoset, 2.4 m/8 ft

by AirLife Finland Oy

Ref 9446-913Model Vital Signs™ Cardiac output injectate probe

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190752TDHEL1211UJ Basic UDI-DI 10190752181397UDI-DIDate24 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number10190752181397 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: not 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  • Withdrawn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  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vital Signs™ Cardiac output in-line injectate probe for GE monitors, ICU Medical Thermoset, 2.4 m/8 ft EUDAMED
Vital Signs™ GUDID
Generic Name
Injectate temperature probe
Model / Ref / Catalog
Vital Signs™ Cardiac output injectate probe, 9446-913
Primary DI / UDI-DI
10190752181397
Basic UDI-DI
0190752TDHEL1211UJ
Direct Marketing DI
10190752181397
FDA Product Code
DQE
EMDN Code
Z12050580 Cardiac output measurement instruments - hardware accessories
GMDN Term
Injectate temperature probe
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1230
EU market of registration
Finland
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001482

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See all devices from AirLife Finland Oy →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No