STERILE 3-WAY INFUSION SET PVC GRAVITY 5.5 DEHP-FREE BPA-FREE 3X4.1, 30CM EXTENSION MOBILE LUER LOCK PURGE FILTER 180CM

Reference : PER3FL25BPAF

  • 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 "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 bars.

Infuser with:

Two-channel perforator 

Air intake (0.2µm filter): Delivered closed for immediate use on a pocket

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15µm 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: Mobile Luer Lock, end cap with 0.8 µm purge filter (hydrophobic membrane) enabling automatic purging of the infusion line.

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

Technical
information

Indications 
This device allows the administration by gravity of injectable preparations by parenteral way: drugs, solutions, 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).

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 ou 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II ou 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
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices;
  • 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 10 x 25 x 1 0.029 3661809029356
BAG 25 48 x 30 x 1 0.750 3661809129353
CASE 250 58 x 40 x 25 9.100 3661809329357

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 bars.

Infuser with:

Two-channel perforator 

Air intake (0.2µm filter): Delivered closed for immediate use on a pocket

Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15µm 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: Mobile Luer Lock, end cap with 0.8 µm purge filter (hydrophobic membrane) enabling automatic purging of the infusion line.

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

Indications 
This device allows the administration by gravity of injectable preparations by parenteral way: drugs, solutions, 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).

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 ou 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II ou 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
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices;
  • 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 10 x 25 x 1 0.029 3661809029356
BAG 25 48 x 30 x 1 0.750 3661809129353
CASE 250 58 x 40 x 25 9.100 3661809329357

Video(s)

Associated products

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 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

Request for technical documentation

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