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polysem medical
polysem medical
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< RETOUR

STERILE 3-WAY INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1, 120CM EXTENSION MOBILE LUER LOCK PURGE FILTER

Reference : PER3120FBPAF

  • 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 INFINEED sterile, DEHP free, BPA free 3-way infusion device 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 bar.

Pre-assembled infusion set in sterile blister packaging with Tritan 3-way stopcock, free from Bisphenol A, sterilised with ethylene oxide (EtO residue <60µg), DEHP-free (<01% m/m)

Perforator: Two-channel with grip wings.

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

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.

3-way stopcock: Free from Bisphenol A, lipid-resistant with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube. Only the main line can be disconnected from the stopcock.

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 3 x 4.1mm

End cap: Mobile Luer Lock.

End stopper: 0.8 μm purge filter with antibacterial membrane.

Technical
information
Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition.

Used materials 
PVC: air intake - PVC DINCH®: Chamber, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Polymer free from BISPHENOL A: Stopcock body - Acrylonitrile butadiene styrene: Perforator, regulator, mobile Luer Lock - 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 : 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
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 3661809025891
BOX 100 38 x 28 x 32 4.350 3661809125898
CASE 400 59 x 39 x 66 18.000 3661809225895
Use
Use

Request the technical sheet

The INFINEED sterile, DEHP free, BPA free 3-way infusion device 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 bar.

Pre-assembled infusion set in sterile blister packaging with Tritan 3-way stopcock, free from Bisphenol A, sterilised with ethylene oxide (EtO residue <60µg), DEHP-free (<01% m/m)

Perforator: Two-channel with grip wings.

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

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.

3-way stopcock: Free from Bisphenol A, lipid-resistant with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube. Only the main line can be disconnected from the stopcock.

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 3 x 4.1mm

End cap: Mobile Luer Lock.

End stopper: 0.8 μm purge filter with antibacterial membrane.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition.

Used materials 
PVC: air intake - PVC DINCH®: Chamber, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Polymer free from BISPHENOL A: Stopcock body - Acrylonitrile butadiene styrene: Perforator, regulator, mobile Luer Lock - 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 : 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 3661809025891
BOX 100 38 x 28 x 32 4.350 3661809125898
CASE 400 59 x 39 x 66 18.000 3661809225895

Video(s)

Associated products

STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 30CM EXTENSION MOBILE LUER LOCK PURGE FILTER 180CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 3-WAY GRAVITY 5.5 60CM EXTENSION MOBILE LUER LOCK PURGE FILTER 210 CM
STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 10CM EXTENSION MOBILE LUER LOCK PURGE FILTER 180CM

Associated products

STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 30CM EXTENSION MOBILE LUER LOCK PURGE FILTER 180CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 3-WAY GRAVITY 5.5 60CM EXTENSION MOBILE LUER LOCK PURGE FILTER 210 CM
STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 10CM EXTENSION MOBILE LUER LOCK PURGE FILTER 180CM

Request for technical documentation

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