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< RETOUR

LINEAR EXTENSION PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE MALE FEMALE LUER LOCK

Reference : PMFML
lenght (cm) 

  • Limited residual volume, internal tube diameter 2.5 mm
  • Pressure resistance: 2 bar
  • Mobile male Luer Lock

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Description
Description

The INFINEED lt;precision plus lt; DEHP free, BPA free PVC extension 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 extension has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bar.

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.
For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.

The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).
Extension with:
Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm
End cap: Mobile Luer Lock equipped with a purge filter.
End stopper: Purge filter
2 bar pressure resistance according to the claim of compliance with reference standard NF EN ISO 8536-9.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.



Technical
information
Technical
information

Indications 
This medical device is intended for the parenteral administration of injectable preparations (drugs, nutrition) by gravity.

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap - Polyethylene: End cap - Acrylonitrile Butadiene Styrene: Mobile male Luer Lock, fixed female Luer lock

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 : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

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
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • 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 9: Fluid lines for single use with pressure infusion equipment

economic operator 

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

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The INFINEED lt;precision plus lt; DEHP free, BPA free PVC extension 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 extension has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bar.

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.
For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.

The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).
Extension with:
Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm
End cap: Mobile Luer Lock equipped with a purge filter.
End stopper: Purge filter
2 bar pressure resistance according to the claim of compliance with reference standard NF EN ISO 8536-9.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.



Indications 
This medical device is intended for the parenteral administration of injectable preparations (drugs, nutrition) by gravity.

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap - Polyethylene: End cap - Acrylonitrile Butadiene Styrene: Mobile male Luer Lock, fixed female Luer lock

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 : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

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
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • 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 9: Fluid lines for single use with pressure infusion equipment

economic operator 

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

Associated products

LINEAR EXTENSION PVC DEHP-FREE BPA-FREE 2.5X4.1MM FIXED MALE FEMALE LUER LOCK

Associated products

LINEAR EXTENSION PVC DEHP-FREE BPA-FREE 2.5X4.1MM FIXED MALE FEMALE LUER LOCK

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