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Bag Materials: |
Polyvinyl chloride (PVC)
Low-density polyethylene (LDPE)
Ethylene vinyl acetate (EVA) |
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Filter Materials: |
Granulated charcoal |
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Bag: |
Made of a flexible, transparent plastic with a non-woven protection layer on the skin side. |
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Shape: |
Anatomically-shaped with smooth edges. Adhesive attachment system: 11x11cm, hydrocolloid skin protector to ensure safe removal. |
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Continuity between the bag and colostomy. |
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Size: |
Bag length: 19cm, width 14cm. |
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Window and aperture starting diameter +/-12mm, markings up to 64mm. |
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Markings: |
Printed cutting marks at 25, 38, 51 and 64mm. |
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Filter: |
To absorb gases and unpleasant smell produced by the bowels. |
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Unit presentation: |
One colostomy bag, medically clean, single-use. |
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Packaging: |
Dependent on supplier, one box with 30 or 40 pieces, . |
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Each carton clearly identified with the product name and characteristics, manufacturer’s address, lot number, number of units per carton, manual and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Storage: |
Protect from direct sunlight and humidity. |
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Other: |
Must comply with Medical Device Directive 93/42/EEC. |