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< RETOUR

1 WAY INFUSION SET FLOW PERFORMANCE ROTARY FLOW REGULATOR

Reference : PER1FLPFB

  • 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.

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Description
Description

The DEHP-free, BPA-free INFINEED 1-way infusion set with rotary flow controller has been designed to minimise the device's environmental impact: Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)

Infuser with:

Two-channel perforator with grip wings.

Air intake: Delivered closed for immediate use on a 0.2µ filter bag.

Chamber: Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.

Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.

End stopper: Mobile Luer Lock equipped with a purge filter with anti-bacterial membrane.

Technical
information
Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. Do not use with high-risk drugs, drugs with a narrow therapeutic range (catecholamines, morphine, heparin, insulin, potassium chloride, anticancer drugs requiring administration by infusion pump, and all pharmaceutical specialties which include in the SPC the need for administration by infusion pump or syringe pump. ) Source: OMEDIT CENTRE -- Best practices for infusion:"Infusion flow accuracy" module.

Used materials 
PVC: Chamber, air intake, tubing - Polyethylene: cap with purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: rotary flow regulator, infusion set, Mobile Luer Lock, fixed Luer Lock tip - Nylon: Particle filter

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 : 123
  • 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
  • Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

Logistics
information
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 11 x 24 x 1 0.032 3661809033841
BOX 50 20 x 37 x 25 1.600 3661809033858
CASE 200 38 x 51 x 41 7.200 3661809033865
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The DEHP-free, BPA-free INFINEED 1-way infusion set with rotary flow controller has been designed to minimise the device's environmental impact: Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)

Infuser with:

Two-channel perforator with grip wings.

Air intake: Delivered closed for immediate use on a 0.2µ filter bag.

Chamber: Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.

Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.

End stopper: Mobile Luer Lock equipped with a purge filter with anti-bacterial membrane.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. Do not use with high-risk drugs, drugs with a narrow therapeutic range (catecholamines, morphine, heparin, insulin, potassium chloride, anticancer drugs requiring administration by infusion pump, and all pharmaceutical specialties which include in the SPC the need for administration by infusion pump or syringe pump. ) Source: OMEDIT CENTRE -- Best practices for infusion:"Infusion flow accuracy" module.

Used materials 
PVC: Chamber, air intake, tubing - Polyethylene: cap with purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: rotary flow regulator, infusion set, Mobile Luer Lock, fixed Luer Lock tip - Nylon: Particle filter

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 : 123
  • 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
  • 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 11 x 24 x 1 0.032 3661809033841
BOX 50 20 x 37 x 25 1.600 3661809033858
CASE 200 38 x 51 x 41 7.200 3661809033865

Request for technical documentation

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