STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY MOBILE LUER LOCK VENT FILTER 300CM

Reference : PER1FL300

  • Bisphenol A and DEHP free (<0.1% m/m.)
  • Designed to reduce the carbon footprint as much as possible.
  • Packaging developed with users to provide excellent readability of the main information needed immediately.

Description

The INFINEED sterile, DEHP free, BPA free 1-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).

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.
- Flow regulator: Accurate and reliable, linear flow regulator.
- Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.
- End fitting: Mobile Luer Lock.
- End stopper: Equipped with a purge filter with anti-bacterial membrane of 0.8µm

Length: 300 cm

Residual volume: 230 ml



Made in China.



Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.

Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral and photosensitive drugs, solutions and nutrition when long tubing is required. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to regulation in member state.

Used materials 
PVC (DEHP < 01.% (m/m)): Chambre, prise d'air, tubulure - DINCH : plastifiant - Polyéthylène : Filtre de purge, capuchon protecteur perforateur, Luer Lock mobile - Acrylonitrile Butadiène Styrène : Perforateur, régulateur de débit linéaire - Polyamide : Filtre à particule

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 

  • 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.

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 0.040 3661809032738
BOX 50 24 x 39 x 29 3.740 3661809032745
CASE 200 42 x 50 x 40 9.620 3661809032752

The INFINEED sterile, DEHP free, BPA free 1-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).

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.
- Flow regulator: Accurate and reliable, linear flow regulator.
- Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.
- End fitting: Mobile Luer Lock.
- End stopper: Equipped with a purge filter with anti-bacterial membrane of 0.8µm

Length: 300 cm

Residual volume: 230 ml



Made in China.



Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and while the luer lock is connected, therefore under physical stress, presents a significant risk of cracking of the luer lock, and should be avoided as much as possible.

In accordance with the recommendations of the SF2H (2019), disinfecting the connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective in disinfecting inert materials and there is much less risk of altering plastic materials.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral and photosensitive drugs, solutions and nutrition when long tubing is required. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to regulation in member state.

Used materials 
PVC (DEHP < 01.% (m/m)): Chambre, prise d'air, tubulure - DINCH : plastifiant - Polyéthylène : Filtre de purge, capuchon protecteur perforateur, Luer Lock mobile - Acrylonitrile Butadiène Styrène : Perforateur, régulateur de débit linéaire - Polyamide : Filtre à particule

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 

  • 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.

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 0.040 3661809032738
BOX 50 24 x 39 x 29 3.740 3661809032745
CASE 200 42 x 50 x 40 9.620 3661809032752

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
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 FIXED LUER LOCK VENT FILTER 170 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM

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
STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 1 WAY GRAVITY 5.5 FIXED LUER LOCK VENT FILTER 170 CM
1-WAY INFUSER STERILE PVC UV FILTER PHOTOPROTECTOR DEHP-FREE BPA-FREE 3X4.1 LUER LOCK MOBILE PURGE FILTER 180CM

Request for technical documentation

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