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

Reference : PER3VF

  • 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 check valve 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 stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bars.

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 antibacterial membrane.

3W stopcocks, free from Bisphenol A.

Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. It is specifically recommended for mixed mechanical and gravity infusion; the check valve must be fitted to the gravity line. 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).

Used materials 
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.

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
  • 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.

economic operator 

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

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 3661809023262
BOX 100 39 x 29 x 27 4.000 3661809123269
CASE 400 60 x 40 x 57 16.000 3661809223266

The INFINEED sterile, DEHP free, BPA free 3-way infusion device with check valve 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 stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bars.

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 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. It is specifically recommended for mixed mechanical and gravity infusion; the check valve must be fitted to the gravity line. 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).

Used materials 
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.

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
  • 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.

economic operator 

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

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 3661809023262
BOX 100 39 x 29 x 27 4.000 3661809123269
CASE 400 60 x 40 x 57 16.000 3661809223266

Video(s)

Associated products

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

Associated products

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

Request for technical documentation

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