Organization name

Philips Medical Systems

SRN

US-MF-000002321

Manufacturer status

Active

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

• Do not re-use

Primary placement in Austria; available across 27 countries total.

Trade name

Esophageal/Rectal Temperature Probe

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.

20884838008483

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.

B-20884838008483

Reference / catalog number

M1837A

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Esophageal/Rectal Temperature Probe Disposable; size 9 Fr; Probe length = 36" (91cm); sterile; minumum shelf life = 12 months; 1 cs = 20 probes; wgt = 1 lb (454g)

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.