Description
Butterfly Standard
Winged Set
Medical device CE 0050, class IIa.Butterfly needles for infusions and/or blood sampling, with needle, guide wings and connecting cannula.
Anti-slip system on the wing of the device (Easy to insert needle into the vein without slipping at the time of application). Designed to connect to another device in accordance with harmonized standards to ensure a complete connection to the other device. Female Luer closure designed in accordance with harmonized standards EN-1707, ANSI/HIMA MD 70.1. Color-coded identification is made in accordance with ISO 6009:1992.
| Code | Needle Gauge | Needle Length | Pipe length | Color | Filling volume | Flow rate |
| 391810901 | 19 G (1.1mm) |
3/4" - 19 mm | Series 12 inches 300mm |
cream | 0.47 ml | 51.2 ml/min |
| 391811001 | 21 G (0.8mm) |
green | 0.44 ml | 26.6 ml/min | ||
| 391811201 | 23 G (0.6mm) |
light blue | 0.44 ml | 9.2 ml/min | ||
| 391811301 | 25 G (0.5mm) |
orange | 0.45 ml | 4.3 ml/min | ||
| 391811401 | 27 G (0.4mm) |
grey | 0.44 ml | 0.6 ml/min |
List of components
All materials used in the construction of the needles are medical grade and LATEX FREE. The tubing is DEHP FREE and crush resistant. The system is composed of:
• polypropylene luer cap;
• Stainless steel needle SUS-304;
• PVC fins and cannula - NON DEHP;
• ABS luer connector;
• epoxy glue.
Packaging and wrapping
Product individually packed in blister type with PET/PE coating. Each pack (indivisible) contains 50 pcs. The outer packaging in double corrugated cardboard boxes contains 20 packs, for a total of 1000 units. Each individual unit is identified by batch number, shelf life and information on sterilization methods. All products are packaged according to the BS EN 868-5/1999 standard which applies to medical devices that must be sterilized.
Sterilization
ETHYLENE OXIDE. Sterile disposable hypodermic needles compliant with ISO 7864:1993. Sterility is ensured by the individual packaging of each unit and by an indicator placed on the external carton.
Warnings
For single use only. Do not resterilize.
Conservation
Store in a dry, clean place.
Validity
5 years (from sterilization) if packaging is intact and stored correctly.
Biocompatibility
All materials are biocompatible in accordance with ISO/ANSI/AAMI 10993.
Product Certification
Complies with Directive 93/42EEC (Annex II) (implemented with Legislative Decree 24 February 1997, n. 46) and subsequent additions.
Code 391810901 / 391811001 / 391811201 / 391811301 / 391811401
