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Unity Network ID

by GE Medical Systems Information Technologies, Inc.

510(k) K103432Ref 5514403

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103432↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00030GM Basic UDI-DI 00195278017949UDI-DIDate15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK103432 Date17 Dec 2010ClearedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
5514403
Primary DI / UDI-DI
00195278017949
Basic UDI-DI
8406821BUG00030GM
510(k) Number
FDA Product Code
MWI
EMDN Code
Z12030299 Vital signs monitoring instruments - other
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.2300
EU market of registration
Belgium
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Unity Network ID is a Network Interface Device (Nomenclature: MWI) designed to facilitate data acquisition and transmission between peripheral medical devices and a central monitoring network. It aggregates digital signals from up to eight supported devices, enabling seamless integration with clinical information systems, central stations, or patient monitors for unified patient monitoring.

This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical environments such as hospitals or healthcare facilities. It operates within the CARESCAPE Network ecosystem and requires no special sterility or single-use handling. Authorized under FDA 510(k) clearance (K103432) and MDR compliance, the Unity Network ID adheres to regulatory standards for cardiovascular-related connectivity solutions.

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical environments is the Unity Network ID designed to support, and how does it integrate with existing systems?

    The Unity Network ID is intended for use in clinical environments like hospitals and healthcare facilities where centralized patient monitoring is required. It connects up to eight peripheral medical devices to a central monitoring network, enabling seamless data aggregation and transmission to clinical information systems, central stations, or patient monitors within the GE Healthcare CARESCAPE Network ecosystem. This allows for unified patient monitoring across multiple devices.

  • Is the Unity Network ID meant for single-use or reusable applications, and what does this mean for maintenance?

    The Unity Network ID is explicitly designed as a reusable, non-sterile medical instrument. This means it is built for repeated use in clinical settings without requiring sterilization between patients, simplifying maintenance workflows and reducing operational costs. However, proper cleaning and routine maintenance per manufacturer guidelines are still necessary to ensure reliable performance and infection control.

  • What types of medical devices can be connected to the Unity Network ID, and how does it ensure compatibility?

    The Unity Network ID is designed to aggregate digital signals from up to eight supported peripheral medical devices within the GE Healthcare CARESCAPE Network ecosystem. Compatibility is ensured through standardized connectivity protocols within this ecosystem, allowing seamless integration with devices designed for unified monitoring. Specific device compatibility should be verified against the manufacturer’s supported device list.

  • How does the Unity Network ID’s regulatory status ensure its safety and reliability in clinical use?

    The Unity Network ID holds both FDA 510(k) clearance (K103432) under a Special decision classification and compliance with the EU Medical Device Regulation (MDR). The FDA’s clearance under the Cardiovascular advisory committee (CV) and the designation as substantially equivalent to a predicate device indicates it meets established safety and performance standards for cardiovascular-related connectivity solutions. MDR compliance further ensures adherence to stringent EU regulatory requirements for medical devices.

Properties

Other properties (13)

  • Sterile: 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