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

Reference : PER310FL25BPAF

  • 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 lt;Gravity lt; 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.

Infusion set with:
- Two-channel perforator with grip wings
- Air intake: with 0.2µm filter. Delivered closed for immediate use on infusion bags.
- 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 connector: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane

Length: 170cm + 10cm

Residual volume: 15.4 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 drugs, solutions and nutrition. 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 DINCH (DEHP<0.1%(m/>)): Chamber, air intake, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: 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
  • 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.

economic operator 

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

Logistics
information

Transport conditions 

Protect from light and humidity and store at a temperature between 5°C and 20°C.

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 10 x 25 x 1 0.030 3661809029387
BAG 25 48 x 29 x 6 0.810 3661809129384
CASE 250 58 x 40 x 25 7.850 3661809229381

The INFINEED lt;Gravity lt; 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.

Infusion set with:
- Two-channel perforator with grip wings
- Air intake: with 0.2µm filter. Delivered closed for immediate use on infusion bags.
- 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 connector: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane

Length: 170cm + 10cm

Residual volume: 15.4 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 drugs, solutions and nutrition. 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 DINCH (DEHP<0.1%(m/>)): Chamber, air intake, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: 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
  • 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.

economic operator 

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

Transport conditions 

Protect from light and humidity and store at a temperature between 5°C and 20°C.

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 10 x 25 x 1 0.030 3661809029387
BAG 25 48 x 29 x 6 0.810 3661809129384
CASE 250 58 x 40 x 25 7.850 3661809229381

Video(s)

Associated products

STERILE PVC GRAVITY 5.5 DEHP-FREE 3-WAY INFUSION SET BPA-FREE 3X4,1 EXTENSION 30CM LUER LOCK MOBILE 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

Associated products

STERILE PVC GRAVITY 5.5 DEHP-FREE 3-WAY INFUSION SET BPA-FREE 3X4,1 EXTENSION 30CM LUER LOCK MOBILE 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

Request for technical documentation

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