STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1 Y-SITE 30CM EXTENSION MOBILE LUER LOCK PURGE FILTER 160CM

Reference : PER3YFL25BPAF

  • 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 DEHP-free, BPA-free INFINEED lt;Gravity lt; 3-way infusion set with Y-site has been designed to minimise 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.) 

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.

The Y-site enables the bypass delivery of bolus drugs using a syringe and needle.

Infuser with:
- Two-channel perforator with grip wings
- Air intake: with 0.2µm filter. Delivered closed for immediate use on a infusion 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
- Latex-free Y-site made from synthetic polyisoprene
- End connector: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane

Length: 100cm+30cm+30cm

Residual volume: 14.9 ml
Made in China.

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). 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, injection site - Nylon: Particle filter - synthetic polyisoprene: injection site

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 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 3661809029363
BAG 25 3661809129360
CASE 250 50 x 40 x 32 9.198 3661809329364
PALLET 5000

The DEHP-free, BPA-free INFINEED lt;Gravity lt; 3-way infusion set with Y-site has been designed to minimise 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.) 

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.

The Y-site enables the bypass delivery of bolus drugs using a syringe and needle.

Infuser with:
- Two-channel perforator with grip wings
- Air intake: with 0.2µm filter. Delivered closed for immediate use on a infusion 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
- Latex-free Y-site made from synthetic polyisoprene
- End connector: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane

Length: 100cm+30cm+30cm

Residual volume: 14.9 ml
Made in China.

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). 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, injection site - Nylon: Particle filter - synthetic polyisoprene: injection site

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 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 3661809029363
BAG 25 3661809129360
CASE 250 50 x 40 x 32 9.198 3661809329364
PALLET 5000

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