Device Dossier

HEMOBLAST Bellows - Collagen haemostatic agent

Device Dossier for HEMOBLAST Bellows - Collagen haemostatic agent (Collagen haemostatic agent, Class III, sponsor Vicki Partridge). ARTG record, intended…

Intended purpose

HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

Functional description

The HEMOBLAST Bellows is a single use, sterile medical device containing an haemostatic powder comprised by collagen, chondroitin sulfate, and thrombin. No preparation, mixing or heating is required as the bellows is pre-loaded with 1.65 g of haemostatic powder and a 10 cm nozzle extension. A laparoscopic applicator is not supplied with the device. Shelf life is 36 months, stored in dry conditions at a temperature range between 2-25C.

TGA Public Summary