L or F ric
First

Medical Device CE 0086, sterile class I.
Urinary catheter, hydrophilic, disposable, self-lubricating with sterile water integrated in the package, for intermittent catheterization. The catheter is hydrated in a sterile environment. The catheter surface is made with Urotonic SurfaceTechnology: the combination of polyvinylpyrrolidone (PVP), salt (NaCl) and the water present in the integrated sachet, makes the LoFric Primoisotonic catheter coating with urine, after activation. The packaging of each single product allows safe catheterization in every situation:
- Sachet with sterile water integrated in the package
- The packaging of each individual product allows manipulation without direct contact with the catheter body, thanks to the presence of a special sheath for the insertion and subsequent extraction of the catheter ("NO-TOUCH" sheath).

All LoFric Primo catheters can be connected to standard urine collection bags.

Benefits
- Possibility of opening in 3 different ways to meet the different needs of users
- Possibility of hanging the package to facilitate catheterization
- Activation: Urotonic Surface Technology reduces friction during catheterization, ensures comfort and reduces the risk of long-term complications
- Presence of a sheath for the insertion and subsequent extraction of the catheter which allows a firm grip and the no-touch technique
- Lateral atraumatic drainage holes for better comfort
- PVC free: POBE, a polyolefin-based elastomer, has a low environmental impact during its entire life cycle ¹
- DEHP free: no risk of loss of plasticizing agents
- LATEX free: no risk of allergic reaction to latex

Manufacturing Materials
Catheter material (including connectors): Polyolefin based elastomer (POBE).
Coating material: polyvinylpyrrolidone (PVP) and salt (NaCl).
Material integrated in the package: sachet containing sterile water in polyethylene terephthalate (PET), polyethylene (PE), aluminum laminate.
All the materials used are tested non-toxic, medical grade and biocompatible materials. PVC, DEHP and latex free.

Warnings
The LoFric Primo catheter is for single use only. Once used, the unique surface coating deteriorates and the catheter is no longer sterile. Risks associated with reuse can be: increased adherence, pain, bleeding, urinary tract infections and long-term strictures and epididymitis.

Format
Box containing 30 catheters. Each catheter is packed in a single blister made up of Polyethylene (PE).

Bibliography
1 Stripple H, Westman R, Holm D “Development and environmental improvements of plastics for hydrophilic catheters in medical care: an environmental evaluation” Journal of Cleaner Production 2008; Vol. 16, No. 16, 1764-1776