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< RETOUR

STERILE 3-WAY INFUSER PVC DEHP-FREE 3X4.1 1 3-WAY FAUCET WITH LUER LOCK ANTI-RETURN VALVE MOBILE PURGING FILTER 235CM

Reference : PER3VF02

  • Without DEHP (<0.1% m/m.)
  • Designed to minimize the environmental footprint by reducing the mass of plastic materials.
  • Packaging with user development to provide very good readability of the main information needed immediately.

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Description
Description

The sterile INFINEED 3-way infuser with non-return valve, DEHP-free, has been designed to minimize its environmental impact, using exclusively DEHP-free raw materials (elimination of components containing DEHP). The polycarbonate-free 3-way stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bars

Infuser with:

Perforator: Two-channel with gripping wings.

Air intake: Delivered closed for immediate use on the bag (except for infusers equipped with a non-return valve) - 1.2? filter.

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15? particle filter.

Caster: Precise and reliable, linear flow regulator

Tubing: PVC, DEHP-free, designed for regularity of adjustment. Tubing diameter: 3 x 4.1mm.

Terminal tip: Mobile Luer Lock.

Terminal cap: 0.8 ?m purge filter with antibacterial membrane.

3V faucet without Bisphenol A.

Polycarbonate and silicone non-return valve.

Technical
information
Technical
information

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.

Logistics
information
Logistics
information

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 06972620110923
CASE 400 56 x 98 x 36 16972620110920
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The sterile INFINEED 3-way infuser with non-return valve, DEHP-free, has been designed to minimize its environmental impact, using exclusively DEHP-free raw materials (elimination of components containing DEHP). The polycarbonate-free 3-way stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bars

Infuser with:

Perforator: Two-channel with gripping wings.

Air intake: Delivered closed for immediate use on the bag (except for infusers equipped with a non-return valve) - 1.2? filter.

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15? particle filter.

Caster: Precise and reliable, linear flow regulator

Tubing: PVC, DEHP-free, designed for regularity of adjustment. Tubing diameter: 3 x 4.1mm.

Terminal tip: Mobile Luer Lock.

Terminal cap: 0.8 ?m purge filter with antibacterial membrane.

3V faucet without Bisphenol A.

Polycarbonate and silicone non-return valve.

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.

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 06972620110923
CASE 400 56 x 98 x 36 16972620110920

Associated products

3-WAY INFUSER STERILE PVC WITHOUT DEHP 3X4.1 2 3-WAY VALVES 1 ANTI-RETURN VALVE LUER LOCK MOBILE PURGING FILTER 235CM

Associated products

3-WAY INFUSER STERILE PVC WITHOUT DEHP 3X4.1 2 3-WAY VALVES 1 ANTI-RETURN VALVE LUER LOCK MOBILE PURGING FILTER 235CM

Request for technical documentation

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