MDR Classification Tool

Is the device non-invasive and intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body?

A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body. Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration.

Yes

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Is the device a blood bag?

2.2b

Blood bags are used for the reliable collection, separation, storage and transport of blood. Rounded blood bag design prevents blood coagulation and ensures the blood and anti-coagulants are properly mixed during separation and transfusion.

Yes

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2.1/2.2a

Can the device be connected to a class IIa, class IIb or class III active device?

OR

Is the device intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues?

In animals and plants, tissue consists of cells that are similar to each other in appearance and that have the same function.

Yes

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