DISPOSABLE SELF-LUBRICATING HYDROPHILIC URINARY CATHETER POBE LUBRICATION BY POLYVINYLPYRROLIDONE INTEGRATED STERILE SALINE SOLUTION LOFRIC PRIMO BAMBINO CH08 20 CM 30 PIECES

Descriptive sheet

L or F ric
First

Medical Device CE 0086, class I sterile.
Hydrophilic, disposable, self-lubricating urinary catheter with sterile water included in the package, for intermittent catheterization. The catheter is hydrated in a sterile environment. The catheter surface is made with Urotonic Surface Technology: the combination of polyvinylpyrrolidone (PVP), salt (NaCl), and the water in the integrated sachet makes the LoFric Primo catheter coating is isotonic with urine after activation. Each product's individual packaging allows for safe catheterization in any situation:
- Sachet with sterile water integrated in the package
- The packaging of each individual product allows handling without direct contact with the body of the catheter, thanks to the presence of a special sheath for insertion and subsequent extraction of the catheter ("NO-TOUCH" sheath).

Product code	Tip	Length	Measure
4110630	LoFric First Child	20 cm	CH06
4110830	LoFric First Child	20 cm	CH08
4111030	LoFric First Child	20 cm	CH10
4140830	LoFric Primo Donna	15 cm	CH08
4141030	LoFric Primo Donna	15 cm	CH10
4141230	LoFric Primo Donna	15 cm	CH12
4141430	LoFric Primo Donna	15 cm	CH14
4130830	LoFric Primo Donna	20 cm	CH08
4131030	LoFric Primo Donna	20 cm	CH10
4131230	LoFric Primo Donna	20 cm	CH12
4131430	LoFric Primo Donna	20 cm	CH14
4131630	LoFric Primo Donna	20 cm	CH16
4131830	LoFric Primo Donna	20 cm	CH18
4100830	LoFric First Man Nelaton	40 cm	CH08
4101030	LoFric First Man Nelaton	40 cm	CH10
4101230	LoFric First Man Nelaton	40 cm	CH12
4101430	LoFric First Man Nelaton	40 cm	CH14
4101630	LoFric First Man Nelaton	40 cm	CH16
4101830	LoFric First Man Nelaton	40 cm	CH18

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

Advantages
- 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 insertion and subsequent extraction of the catheter which allows for a firm grip and the no-touch technique
- Atraumatic lateral drainage holes for improved comfort
- PVC free: POBE, a polyolefin-based elastomer, has a low environmental impact throughout 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 elastomer (POBE).
Coating material: polyvinylpyrrolidone (PVP) and salt (NaCl).
Material included in the package: sachet containing sterile water in polyethylene terephthalate (PET), polyethylene (PE), aluminum laminate.
All materials used are tested to be non-toxic, medical-grade, and biocompatible. Free from PVC, DEHP, and latex.

Warnings
The LoFric Primo catheter is intended for single use. Once used, the unique surface coating deteriorates and the catheter is no longer sterile. Risks associated with reuse may include increased adhesion, pain, bleeding, urinary tract infections, and, in the long term, strictures and epididymitis.

Format
Box containing 30 catheters. Each catheter is packaged in a single polyethylene (PE) blister pack.

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