Indications
Ce dispositif permet l'administration par gravité de préparations injectables par voie parentérale: médicaments, solutés, nutrition parentérale.
Il est particulièrement recommandé lors de perfusion mixte mécanique et par gravité la valve anti-retour doit être posée sur la ligne gravité.
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.