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Components: |
Bottle with integral handle, removable protective cap. |
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Adjustable straw |
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Bed hangers |
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Disposable stand |
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Tubing sets |
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Material: |
Bottle: PVC |
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Tubing: translucent silk-finish PVC |
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Specifications: |
Bottle with 2 chambers and an overall capacity of 2000ml. |
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a) Small chamber: 500ml with clearly-marked Prime Level (water seal = 200ml).
Permits an accurate measure for the first 500ml, which is important for children. |
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Adjustable, graduated straw. |
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Screw cap with rubber gasket, used to secure water seal tightness. |
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b) Large chamber: 1500ml for complementary drainage. |
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Write-on strip: beside each chamber, with scale for continuous monitoring of drainage progress. |
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Venting and suction port: removable protective cap, non-occluding. The port is situated on the top of the bottle for verification ease and protection. |
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Unit presentation: 1 bottle, sterile, single-use. |
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Packaging: |
Unit presentation: Must be supplied in double packaging: one interior layer (non-woven drape) plus an outer sterilized peel pack.
Labelling: Name and/or trademark of the manufacturer, "sterile", 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 with 1-unit presentation, labelling to be the same as 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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Outer packaging: |
Packaging unit: strong carton |
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Other: |
When using a suction machine: maximum recommended vacuum is 5kPa. Chest drainage bottle can withstand a maximum vacuum of 13kPa (consult the supplier’s instructions for use). |
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Quality: |
Complies with Medical Device Directive 93/42/EEC |