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

Reference : PER3R3VF02

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

Description

The 3-way infuser, INFINEED with 2 taps, sterile, DEHP-free, has been designed to minimize its environmental impact, using exclusively DEHP-free raw materials (elimination of components containing DEHP). Polycarbonate-free 3-way stopcocks have 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) - 1.2μ filter.

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15μ 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 μm purge filter with hydrophobic antibacterial membrane.

3V faucets without Bisphenol A.

Polycarbonate and silicone non-return valve.

Technical
information

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.

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 06972620110671
CASE 200 54 x 56 x 36 16972620110678

The 3-way infuser, INFINEED with 2 taps, sterile, DEHP-free, has been designed to minimize its environmental impact, using exclusively DEHP-free raw materials (elimination of components containing DEHP). Polycarbonate-free 3-way stopcocks have 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) - 1.2μ filter.

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15μ 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 μm purge filter with hydrophobic antibacterial membrane.

3V faucets without Bisphenol A.

Polycarbonate and silicone non-return valve.

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.

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 06972620110671
CASE 200 54 x 56 x 36 16972620110678

Associated products

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

Associated products

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

Request for technical documentation

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