Device Dossier
Compress, hot/cold pack, single use
Device Dossier for Compress, hot/cold pack, single use (Compress, hot/cold pack, single use, Class IIa, sponsor Gel Ice Company). ARTG record, intended…
- GMDN category: Compress, hot/cold pack, single use
Intended purpose
The Medical Device is a cold pack, intended to assist with swelling after sporting injuries, tooth extraction, temporary relief of headaches, migraines and minor burns. The product is presented in a pouch form and is single use only. The pouch contains water and an inner pouch containing urea. Pursuant to Instructions for Use, the process of rupturing the inner pouch, activates an endothermic reaction which in turn lowers the temperature of the device and as such making it usable.