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< RETOUR

STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 30CM EXTENSION FIXED LUER LOCK PURGE FILTER 190CM

Reference : PER3FFL25BPAF

  • 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 "Gravity" 3-ways infusion set without DEHP, BPA-free was designed to minimize the environmental impact of the device. 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.) 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.

Infuser with:

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: ABS linear flow control for good roller clamp rigidity, precision and reliability.

BPA-free 3-way stopcock: 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: Fixed Luer Lock

End stopper: 0.8 µm purge filter with hydrophobic membrane.

Length: 150cm+30cm
Residual volume: 15.8 ml

 

Technical
information
Technical
information

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

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 : CE0123
  • EU directive/regulation : 93/42/CEE modifié par 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 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 3661809033032
BAG 25 0.750 3661809033049
CASE 250 39 x 59 x 27 8.000 3661809033056
Request the technical sheet

The INFINEED "Gravity" 3-ways infusion set without DEHP, BPA-free was designed to minimize the environmental impact of the device. 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.) 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.

Infuser with:

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: ABS linear flow control for good roller clamp rigidity, precision and reliability.

BPA-free 3-way stopcock: 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: Fixed Luer Lock

End stopper: 0.8 µm purge filter with hydrophobic membrane.

Length: 150cm+30cm
Residual volume: 15.8 ml

 

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

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 : CE0123
  • EU directive/regulation : 93/42/CEE modifié par 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 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 3661809033032
BAG 25 0.750 3661809033049
CASE 250 39 x 59 x 27 8.000 3661809033056

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

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