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< RETOUR

MALE FEMALE EXTENSION 3 WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM FIXED LUER LOCK

Reference : PR3LVFLFBPAF
lenght (cm) 

  • Limited residual volume, internal tube diameter 2.5 mm
  • Pressure resistance: 2 bar
  • Fixed male Luer Lock
  • Tritan BPA-free 3-way stopcock

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Description
Description

The INFINEED lt;precision plus lt; 3-way 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:
- BPA-free 3-way stopcock: Lipid-resistant (96 hours to 7 days) with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube.

- 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: 0.8 µm purge filter with hydrophobic membrane


Resistance to pressure of 2 bar according to the claim of compliance with reference standard NF EN ISO 8536-9, 10 bar according to tests performed by Didactic (see scientific and technical file: Lipid-resistant from 96 hours to 7 days)

Made in China.

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, nutrients) by gravity, and/or for active infusion devices whose pressure does not exceed 2 bars. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to regulation in member state.

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve - Tritan® BPA-free: Stopcock body - 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 : 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
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized 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 10: Accessories for fluid lines for single use with pressure infusion equipment
  • 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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Request the technical sheet

The INFINEED lt;precision plus lt; 3-way 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:
- BPA-free 3-way stopcock: Lipid-resistant (96 hours to 7 days) with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube.

- 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: 0.8 µm purge filter with hydrophobic membrane


Resistance to pressure of 2 bar according to the claim of compliance with reference standard NF EN ISO 8536-9, 10 bar according to tests performed by Didactic (see scientific and technical file: Lipid-resistant from 96 hours to 7 days)

Made in China.

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, nutrients) by gravity, and/or for active infusion devices whose pressure does not exceed 2 bars. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to regulation in member state.

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve - Tritan® BPA-free: Stopcock body - 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 : 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
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized 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 10: Accessories for fluid lines for single use with pressure infusion equipment
  • 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 3-WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE LUER LOCK VENT FILTER

Associated products

MALE FEMALE EXTENSION 3-WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE LUER LOCK VENT FILTER

Request for technical documentation

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