Organization name

Philips Medizin Systeme Böblingen GmbH

SRN

DE-MF-000006026

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• MR UNSAFE

Primary placement in Austria; available across 27 countries total.

Trade name

Temperature Parameter Module

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.

00884838108561

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.

0884838BM1149MC

Reference / catalog number

867394

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous.

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.

• Z1203020299MULTI–PARAMETER MONITORS - OTHER

• Class IIa medical devices in EUDAMED

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