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Materials: |
Made of polypropylene (PP). |
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Description: |
3-peice syringe: |
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Barrel: Transparent with contrast graduation: permanent markings and good legibility. |
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Plunger stopper with backstop. |
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Double sealing ring on plunger. |
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Graduation in ml for the volume dosage. |
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With centric-catheter fitting cone for a tube with a funnel connection (e.g., gastric tube). |
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With Luer adapter and aspiration grip for a tube with a Luer connection (e.g., feeding catheter). |
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The removable Luer adapter is located inside the barrel. |
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Quality requirement: |
Must comply with Medical Device Directive 93/42/EEC standard. |
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ISO 10993-1:2003: Biological evaluation of medical devices -- Part 1: Evaluation and testing |
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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 syringe, sterile, peel pack, single-use |
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Primary packaging: |
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with sterilization method, lot number, expiry date by year and month, "for single use", and 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 100-unit presentation; labelling is the same as that of the primary packaging, and multilingual user instructions: English, French and Spanish, others when available. |
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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, when applicable, and quantity of secondary packages. |