Materials: |
Polyvinyl chloride (PVC), medical grade. |
Description: |
- Consists of a hollow cylindrical tube with a central channel for rectal infusion or drainage. |
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- At patient end: tip has central opening with soft round edges |
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- At proximal end: funnel or cup connector (conical tip) |
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- Size: length 30-40cm, diameter CH25 |
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- Sterilization: either ethylene oxide gas or gamma radiation. |
Unit presentation: |
1 tube, sterile, single-use, peel pack. |
Primary packaging: |
Must be supplied in sterilized peel pack sachets. Labelling should mention: manufacturer’s name and/or trademark. "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number for notifying body, product description and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
Secondary packaging: |
Protected unit, one (1) box, 1-unit presentation, labelling is the same as that of primary packaging. |
Additional required information: |
Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
Quality: |
Norms: Must comply with: |
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- Medical Device Directive 93/42/EEC, risk class II a |
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- EN 550 gas sterilization ethylene oxide |
Unit presentation: |
1 tube, sterile, single-use |
Packaging: |
Primary packaging: Must be supplied in a sterile peel pack. Labelling should mention: manufacturer’s name and/or trademark. "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, product description, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: Protected unit, one (1) box with xxxx -unit presentation; labelling is the same as that of primary packaging. |
Additional required information: |
Number of units per secondary packaging and information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
Other requirements: |
Quality must comply with Medical Device Directive 93/42/EEC. |