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< RETOUR

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 FIXED LUER LOCK VENT FILTER 170 CM

Reference : PER1FFL25

  • 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 lt;Gravity lt; 1-way infusion set was designed to minimize 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.)

- Two-channel perforator
- Air intake: Delivered closed for immediate use on a 0.2µm filter bag.
- Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, with 15µm particle filter.
- Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
- End fitting: Fixed Luer Lock
- End stopper: Equipped with a very pressure-resistant purge filter with antibacterial membrane of 0.8µm.

Length: 160 cm

Residual volume: 15 ml

Technical
information
Technical
information

Indications 
This device enables parenteral administration of injectable preparations by gravity. 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 (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: 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 : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • Sterilization of health-care products - Ethylene oxide - Part 1 : Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • 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 3661809029370
BOX 25 3661809129377
CASE 250 3661809229374
Use
Use

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The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set was designed to minimize 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.)

- Two-channel perforator
- Air intake: Delivered closed for immediate use on a 0.2µm filter bag.
- Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, with 15µm particle filter.
- Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
- End fitting: Fixed Luer Lock
- End stopper: Equipped with a very pressure-resistant purge filter with antibacterial membrane of 0.8µm.

Length: 160 cm

Residual volume: 15 ml

Indications 
This device enables parenteral administration of injectable preparations by gravity. 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 (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: 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 : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • Sterilization of health-care products - Ethylene oxide - Part 1 : Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • 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 3661809029370
BOX 25 3661809129377
CASE 250 3661809229374

Video(s)

Associated products

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 SITE Y LUER LOCK MOBILE PURGE FILTER 150+30CM

Associated products

STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 MOBILE LUER LOCK VENT FILTER 160 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 SITE Y LUER LOCK MOBILE PURGE FILTER 150+30CM

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