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Vital Signs™ direct connect temperature cable for GE monitors, 400 series, single, 3.6 m/12 ft

by AirLife Finland Oy

Ref 2021701-001Model Vital Signs™ temperature cable for GE monitors, 400 series, dual, 0.5 m/20 in

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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/MDR EUDAMED Number088948320041eTempProb2R6 Basic UDI-DI 10889483576304UDI-DIDate19 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483576304 UDI-DI Date26 Mar 2025ListedStatusListed 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

1 recall · FDA

    • Terminated Z-1959-2013 FDA Class II initiated 18 Jul 2013

    GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe

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  • Withdrawn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
Vital Signs™ direct connect temperature cable for GE monitors, 400 series, single, 3.6 m/12 ft EUDAMED
Vital Signs™ GUDID
Generic Name
Electrical-only medical device connection cable, reusable
Device Name
Vital Signs™ temperature cable
Model / Ref / Catalog
Vital Signs™ temperature cable for GE monitors, 400 series, dual, 0.5 m/20 in, 2021701-001
Primary DI / UDI-DI
10889483576304
Basic UDI-DI
088948320041eTempProb2R6
Direct Marketing DI
10889483576304
510(k) Number
FDA Product Code
FLL
EMDN Code
Z129080 Various instruments for functional exploration and therapeutic interventions - hardware accessories
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.2910
EU market of registration
Finland
GUDID distribution status
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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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