Components and materials: |
Catheter hub: Teflon fluoro ethyl propylene (FEP) . |
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Fixation wing. |
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Injection port with closing cone. |
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Luer-lock fitting. |
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Introducing guide / trocar. |
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Internal needle or trocar: stainless steel. |
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Protective cap. |
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Handgrip. |
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Stopper. |
Specifications: |
Hub: cannula part which remains inserted. |
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Catheter (distal part): transparent, straight with 2-4 fully embed X-ray contrast lines, tapering end. |
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The X-ray line allows better control over the catheter and the internal needle when doing a vein puncture under poor lighting conditions. |
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Injection port: has a bacterial filter and a removable reusable cap or cone (for closing) attached with a fixed strap. |
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The cap should be free of protuberances. |
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Fixation wing: sloped supporting surface to compensate for puncture gradient. |
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Luer connection (proximal part): for attachment of an infusion, syringe with Luer-lock fitting. |
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Luer connection (proximal part): for attachment of an infusion, syringe with Luer-lock fitting. |
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Internal needle or trocar with bevelled edge ensures a good skin penetration and reduces vein trauma. The internal needle is connected to a transparent flashback chamber with handgrip and stopper. |
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The transparent base enables monitoring for blood reflux when a vein is punctured. |
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Colour-coded hub and cannula, by size: |
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- 16G 1.7 x 50mm, grey: average flow 196ml/mm, for transfusion or rapid infusion. |
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- 18G 1.3 x 45mm, green: average flow 96ml/mm, for transfusion or rapid infusion |
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- 20G 1.1 x 33mm, pink: average flow 61ml/mm, adult use. |
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- 22G 0.9 x 25mm, blue: average flow 36ml/mm, paediatric use. |
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- 24G: 0.7 x 19mm, yellow: average flow 18ml/mm, neonatal use. |
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Recommended brands: B. Braun, Becton Dickinson. |
Unit presentation: |
Sterile, individually peel packed, single-use |
Primary packaging: |
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with method indicated, lot number, expiry date by year and month, "for single use", and CE mark and reference number for notifying body. Must be multilingual: English, French and Spanish, others when available. |
Secondary packaging: |
Protected unit, one (1) box 25- or 50-unit presentation; labelling is the same as that of the primary packaging. |
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Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
Transport packaging: |
Labelling same as secondary packaging and product-specific transport instructions and storage, where required, and quantity of secondary packages. |
Other Requirements: |
Quality must comply with Medical Device Directive 93/42/EEC or equivalent. Meets the following standards:
EN-ISO 10555-1: Sterile, single-use intravascular catheters - Part 1: General requirements
EN-ISO 20594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment
- Part 1: General requirements (ISO 594-1:1986) |