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Materials: |
Silicone-coated natural latex. |
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Components: |
A catheter consists of a hollow 2-way cylindrical tube with: |
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- 1 central channel for urinary drainage. |
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- Bladder side ends in a round or cylindrical atraumatic tip with 2 opposing eyelets. |
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- Collector side has a universal and hollow truncated cone (funnel) to connect the urine bag, spigot, syringe or irrigating device. |
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- 1 side channel for balloon inflation: ending in a non-return valve with a Luer connection and 1 inflatable balloon. |
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Specifications: |
Length: +/-30cm children; +/-40cm adults |
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Diameter ranges: children CH 08 and CH 10; adults CH 12 to CH 20 |
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Balloon expansion capacity: children 3-5ml; adults 15ml |
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Catheter size and balloon capacity must be indicated on the catheter. |
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For safety, the catheter must be double packaged. |
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Unit presentation: |
1 catheter, sterile, single-use, double-packaged: an interior layer and an outer peel pack. |
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Primary packaging: |
Labelling: Name and/or trademark of 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 10-unit presentation, labelling is the same as primary packaging.
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: |
Complies wiht the norm EN 1616: Sterile urethral catheter for single use.
Medical device directive 93/42/EEC, risk class IIa |