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Nerve Monitoring Patient Interface

by Medtronic Xomed Inc

Ref NIM4CPB1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 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
United StatesGUDID listing GUDID Number00763000843915 UDI-DI Date22 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0763000B00025127U Basic UDI-DI 00763000843915UDI-DIDate22 Jun 2026RegisteredStatusActive

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

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1623-2025 FDA Class II initiated 10 Mar 2025

    Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

    • Ongoing Z-2409-2024 FDA Class I initiated 24 Jun 2024

    Potential for false negative response on the NIM Vital Nerve Monitoring System

  • 2 recalls, same reason

    • Ongoing Z-1224-2022 FDA Class II initiated 3 May 2022
    • Ongoing Z-1223-2022 FDA Class II initiated 3 May 2022

    Software anomaly was identified.

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  • Withdrawn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
NIM Vital
Generic Name
Nerve-locating system
Device Name
Nerve Monitoring Patient Interface
Model / Reference
NIM4CPB1
Primary DI / UDI-DI
00763000843915
Basic UDI-DI
0763000B00025127U
510(k) Number
FDA Product Code
GWF, ETN
EMDN Code
Z121002 Nervous system monitoring systems
GMDN Term
Nerve-locating system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1870, 874.1820
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000023264
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No