640647

Organization name

Bracco Injeneering SA

SRN

CH-MF-000019387

Manufacturer status

Active

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• CW010

  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

not provided

UDI-DI code

D-640647Q9

Basic UDI-DI

B-640647Q9

Reference / catalog number

640647

Issuing entity

EUDAMED

Risk category

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.

• Z11039014MULTIPLE CONTRAST AGENT INJECTORS

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