STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 2 STOPCOCKS 3 WAY 1 CHECK VALVE MOBILE LUER LOCK VENT FILTER 235CM

Référence : PER3R3VF

  • Bisphenol A and DEHP free (<0.1% m/m.)
  • Designed to minimise the environmental footprint by reducing the weight of plastic materials.
  • Packaging developed with users to provide excellent readability of the main information needed immediately.

Description

The INFINEED sterile, DEHP free, BPA free 3-way infusion device with 2 stopcocks has been designed to minimise its environmental impact, using only raw materials that are free from endocrine disruptors (elimination of components, including DEHP or BPA). The 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 bar.

Infusion set with:

Perforator: Two-channel with grip wings.

Air intake: Delivered closed for immediate use on a bag (except infusion sets equipped with a check valve) - 1.2μ filter.

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

Flow regulator: Accurate and reliable, linear flow regulator

Tubing: PVC (DINCH) designed for flow adjustment. Tubing diameter: 3 x 4.1mm

End cap: Mobile Luer Lock.

End stopper: 0.8 μm purge filter with hydrophobic antibacterial membrane.

3W stopcocks, free from Bisphenol A.

Informations
techniques

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition when the use of two 3-way stopcocks is required (anaesthesia, obstetrics). 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).

Matériaux utilisés 
PVC: Chamber, air intake - PVC DINCH: Tubing - Polyethylene: Purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: Perforator, mobile Luer Lock, linear flow controller - Nylon: Particle filter - Acrylic: Check valve - Polypropylene: Stopcock protective stoppers - high-density polyethylene HDPE: Stopcock valve - Tritan® copolymer, BPA-free: Stopcock body - Silicone: Lubricant.

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

dispositif médical 

  • MD class : IIa
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

stérile 

  • stérile : yes
  • sterilization method : ethylene oxide

conformité 

  • 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.

opérateur économique 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Informations
logistiques

Conditions de transport 

Protected from light, humidity and heat

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1 3661809014604
BOX 50 39 x 29 x 21 2.250 3661809114601
CASE 200 3661809214608

The INFINEED sterile, DEHP free, BPA free 3-way infusion device with 2 stopcocks has been designed to minimise its environmental impact, using only raw materials that are free from endocrine disruptors (elimination of components, including DEHP or BPA). The 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 bar.

Infusion set with:

Perforator: Two-channel with grip wings.

Air intake: Delivered closed for immediate use on a bag (except infusion sets equipped with a check valve) - 1.2μ filter.

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

Flow regulator: Accurate and reliable, linear flow regulator

Tubing: PVC (DINCH) designed for flow adjustment. Tubing diameter: 3 x 4.1mm

End cap: Mobile Luer Lock.

End stopper: 0.8 μm purge filter with hydrophobic antibacterial membrane.

3W stopcocks, free from Bisphenol A.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition when the use of two 3-way stopcocks is required (anaesthesia, obstetrics). 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).

Matériaux utilisés 
PVC: Chamber, air intake - PVC DINCH: Tubing - Polyethylene: Purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: Perforator, mobile Luer Lock, linear flow controller - Nylon: Particle filter - Acrylic: Check valve - Polypropylene: Stopcock protective stoppers - high-density polyethylene HDPE: Stopcock valve - Tritan® copolymer, BPA-free: Stopcock body - Silicone: Lubricant.

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

dispositif médical 

  • MD class : IIa
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

stérile 

  • stérile : yes
  • sterilization method : ethylene oxide

conformité 

  • 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.

opérateur économique 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Conditions de transport 

Protected from light, humidity and heat

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1 3661809014604
BOX 50 39 x 29 x 21 2.250 3661809114601
CASE 200 3661809214608

Vidéo(s)

Produits associés

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 1 STOPCOCK 3-WAY 1 CHECK VALVE MOBILE LUER LOCK VENT FILTER 235CM

Produits associés

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 1 STOPCOCK 3-WAY 1 CHECK VALVE MOBILE LUER LOCK VENT FILTER 235CM

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