Organization name

Bracco Injeneering SA

SRN

CH-MF-000019387

Manufacturer status

Active

D-640647Q9

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

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

• Consult instructions for use

  Refer to the Operator Manual of CT Exprès Evo or other labeling for a complete list of warnings and cautions.

Primary placement in Sweden; available across 19 countries total.

Trade name

CT Expres Patient Set Evo

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.

D-640647Q9

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-640647Q9

Reference / catalog number

640647

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.

EUDAMED

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

he Patient Set Evo is intended to be used with the CT Exprès Evo Contrast Media Delivery System, the Bottle Spike A and the Day Set III HP, indicated for controlled automatic venous-side administration of contrast media and saline to human subjects while undergoing examination by means of a computed tomography (CT) scanner, including CT angiography (CTA). The Patient Set Evo is intended for a single patient use only, for no more than 12 hours, and for a maximum of three injections (200 mL per injection) or 200 mL of contrast media, whichever occurs first. After its use with a patient, it must be discarded. The CT Exprès Evo contains a non-reuse feature which recognizes and accepts the Patient Set Evo when inserted the first time and rejects it when inserted a second time.

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.

• Z11039014MULTIPLE CONTRAST AGENT INJECTORS

• Class IIa medical devices in EUDAMED

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