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1 first aid dressing: |
One gauze bandage, 10cmx4m, material: cotton with: |
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- 1 fixed compress 10x12cm, material: viscose-fleece with a 2g/m² absorption capacity |
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- 1 removable compress 10x12cm (same material as fixed compress) |
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- Two safety pins |
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Direction of use: |
Remove wrapping. |
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Do not touch bandage material or wound. |
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Pull gauze bandage with both hands. |
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Dress wound with bandage material. |
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Shift the second compress, if required, by pulling on the loop and place it on the wound. |
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Wrap bandage around and fasten with safety pins. |
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Unit presentation: |
1 first aid dressing, sterile, single-use, in peel pack. |
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Description: |
None woven fabric with 3 layers: |
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Layer 1: Viscose or Polyester 100% non-woven fleece, aluminium vaporised |
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Layer 2: Viscose 100% or 60% + 40% Polyester, non-woven fleece |
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Layer 3: 100 Viscose or 100% hydrophobic Polypropylene none woven fleece |
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- The middle layer acts as an absorption cushion |
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- Absorption capacity : +/- 1.400 g/m2 |
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- Colour: Wound side silvery grey |
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- Elastic gauze bandage: width: 6cm wide, fixed on external side (white) top and bottom, to secure dressing in place |
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Unit presentation: |
1 aluminised compress/pad, sterile, single use, in peel packed sachet |
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Labelling: |
Primary packaging/ Unit presentation: Product name, reference number, size, Sterile – sterilisation mode, Lot number, Expiry date by year and month; "for single use";. Mark CE + Notify body number, manufacturer name and addressee. |
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Secondary packaging: |
Labelling to be the same as primary packaging. |
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Extra information required: Number of units |
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Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate |
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Over packaging: |
Packaging unit: Strong carton board |
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Other requirements: |
Comply with European Medical Device Directive 93/42/EEC |
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For MDREFAIDA4: Non-adherent wound dressing, sterile, Class IIb |