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3-way stopcock: |
Materials: polycarbonate |
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A rotating device with 3 connections with 3-way valves and a handle that turns 360°. |
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- 1 Luer male connection near the patient end. |
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- 2 Luer female connections near the IV line. |
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Tubing: |
- Materials PVC |
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- Length 10cm with a male Luer lock connection on the patient end. |
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- Transparent to enable bubble detection, supple, resistant to kinking. |
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The tubing cannot be removed from the 3-way stopcock |
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Quality requirements: |
Complies with European Medical Device Directive Council directive 93/42/EEC or equivalent. |
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Meet standard: |
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). |
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Unit presentation: |
1 unit, sterile, individually peel packed, single-use. |
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Primary packaging: |
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" and method, lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box with 50- or 100-unit presentation, labelling is the same as 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.). |
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Transport packaging: |
Labelling: same as secondary packaging with product-specific transport and storage instructions and quantity of secondary packaging. |
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Protective packaging: |
Carton, labelling is the same as the unit presentation including indication of total quantity. |