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Nellcor Compatible SpO2 Interconnect Cables

by GE Healthcare Finland Oy 4 variants

Ref 2021406-002

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00050GT Basic UDI-DI 00840682103084UDI-DIDate15 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682103084 UDI-DI Date16 Jun 2016ListedStatusListed 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 · 1 ongoing · FDA

    • Ongoing Z-0521-2019 FDA Class II initiated 31 Aug 2018

    The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

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  • Withdrawn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

Generic Name
Electrical-only medical device connection cable, reusable
Device Name
Nellcor Compatible SpO2 Interconnect Cables
Model / Ref / Catalog
2021406-002, OXIMAX, 1.2M
Description
OXIMAX, 1.2M ,2021406-002
Primary DI / UDI-DI
00840682103084
Basic UDI-DI
8406821BUG00050GT
Direct Marketing DI
00840682103084
510(k) Number
FDA Product Code
MHX
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2021406-002
GUDID
OXIMAX, 1.2M,2021406-002
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Prescription Use

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
  • 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
  • Manufacturing Date: No