Device Dossier
AbbVie ENFIT J - Gastrojejunostomy tube
Device Dossier for AbbVie ENFIT J - Gastrojejunostomy tube (Gastrojejunostomy tube, Class III, sponsor AbbVie). ARTG record, intended purpose, GMDN…
- GMDN category: Gastrojejunostomy tube
- Sponsor: AbbVie
Intended purpose
The AbbVie ENFit J is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie PEG for ENFit or AbbVie PEG. The AbbVie ENFit J is indicated for the administration of the medication Duodopa® (Levodopa- Carbidopa Intestinal Gel) for patients with advanced Parkinson’s disease.
Functional description
The AbbVie ENFit J is a 9 FR, intestinal (J) tube with a polyurethane tube that contains a 1.5 cm stainless steel tube and soft polyurethane tip assembly. The overall length is 116 cm. It is intended to provide long-term enteral access for administration of medication Duodopa® (Levodopa-Carbidopa Intestinal Gel) to the small intestine when used in conjunction with the AbbVie PEG for ENFit or AbbVie PEG for patients with advanced Parkinson's disease.