Description

Needle: With triple bevel ensuring excellent skin penetration, Device with 2 wings, standardized colour, foldable, Tubing: Flexible and transparent PVC, Connection: Female Luer Lock, Protection: Needle protector to maintain the integrity of the needle, stopper to protect the female Luer Lock tip.

Technical
information

Indications 
Injection for infusion

Used materials 
Polypropylene: Protective cap for needle, protective cap for female Luer - Siliconized stainless steel: Needle - PVC: Tubing, wings, female Luer Lock tip.

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 : 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
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

Needle: With triple bevel ensuring excellent skin penetration, Device with 2 wings, standardized colour, foldable, Tubing: Flexible and transparent PVC, Connection: Female Luer Lock, Protection: Needle protector to maintain the integrity of the needle, stopper to protect the female Luer Lock tip.

Indications 
Injection for infusion

Used materials 
Polypropylene: Protective cap for needle, protective cap for female Luer - Siliconized stainless steel: Needle - PVC: Tubing, wings, female Luer Lock tip.

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 : 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
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

Request for technical documentation

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