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

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

Description

The INFINEED "precision plus" 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.

Extension with:

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm

End cap: Fixed Luer Lock

End stopper: Polypropylene cap

2 bar pressure resistance according to the claim of compliance with reference standard NF EN ISO 8536-9.

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: Fixed 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 : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/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
  • 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-

The INFINEED "precision plus" 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.

Extension with:

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm

End cap: Fixed Luer Lock

End stopper: Polypropylene cap

2 bar pressure resistance according to the claim of compliance with reference standard NF EN ISO 8536-9.

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: Fixed 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 : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/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
  • 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

MALE FEMALE EXTENSION PVC DEHP-FREE PHOTOPROTECTOR FOR SYRINGE PUMP 1.5X2.5MM FIXED LUER LOCK
LINEAR EXTENSION PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE MALE FEMALE LUER LOCK

Associated products

MALE FEMALE EXTENSION PVC DEHP-FREE PHOTOPROTECTOR FOR SYRINGE PUMP 1.5X2.5MM FIXED LUER LOCK
LINEAR EXTENSION PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE MALE FEMALE LUER LOCK

Request for technical documentation

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