Indications 
This device allows the administration by gravity of parenteral injectable preparations: medications, solutions, parenteral nutrition when the use of two 3-way taps is required (anesthesia, obstetrics). On the peripheral route, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum duration of installation of the peripheral catheter). On the central line, the infusion line must be changed at least every 72 hours (or according to the establishment's validated protocol).

Used materials 
PVC: Chamber, air intake, DEHP-free tubing. Polyethylene: Purge filter, cap, perforator protector. Acrylonitrile Butadiene Styrene: perforator, mobile Luer Lock, linear flow regulator. Nylon: Particle filter. PC: Non-return valve. Polypropylene: Protective tap caps. High density polyethylene HDPE: Faucet key. BPA-free Tritan ® copolymer: Faucet body. Silicone: Lubricant, tap, non-return valve.

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 : CE0197
• EU directive/regulation : Directive 93/42/CEE
• annexe : V

sterile 

• sterile : yes
• sterilization method : ethylene oxide

conformity 

• Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• 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.