Organization name

Philips Medical Systems

SRN

US-MF-000002321

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  Consult IFU

• MR UNSAFE

  These cables are not suitable for use in an MRI environment which could create a potential for patient burns or inaccurate measurements.

Primary placement in Austria; available across 27 countries total.

Trade name

MX40 Adapter 6-Lead + Masimo SpO2

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00884838091276

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0884838BM332SN

Reference / catalog number

989803204291

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

MX40 Adapter 6-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue connector style disposable and reusable ECG leadsets and DIN prewired electrodes on the MX Telemetry Systems. Supports Masimo SpO2 acce

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z1203020202TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.