Device Dossier
Blood collection set
Device Dossier for Blood collection set (Blood collection set, Class IIa, sponsor Smiths Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Blood collection set
Intended purpose
A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.