Indications 
This device enables parenteral administration of injectable preparations by gravity. For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum time the peripheral catheter can be in place). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol).

Used materials 
PVC (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: Particle filter

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

• MD class : IIa
• MD notified body : 0123
• EU directive/regulation : 93/42/CEE - 2007/47/CEE
• annexe : V

sterile 

• sterile : yes
• sterilization method : ethylene oxide

conformity 

• Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• Sterilization of health-care products - Ethylene oxide - Part 1 : Requiremnets for the development, validation and routine control of a sterilization process for medical devices
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

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