Dressing, first aid

1 first aid dressing:

One gauze bandage, 10cmx4m, material: cotton with:

- 1 fixed compress 10x12cm, material: viscose-fleece with a 2g/m² absorption capacity

- 1 removable compress 10x12cm (same material as fixed compress)

- Two safety pins

Direction of use:

Remove wrapping.

Do not touch bandage material or wound.

Pull gauze bandage with both hands.

Dress wound with bandage material.

Shift the second compress, if required, by pulling on the loop and place it on the wound.

Wrap bandage around and fasten with safety pins.

Unit presentation:

1 first aid dressing, sterile, single-use, in peel pack.

Description:

None woven fabric  with  3 layers:

Layer 1:  Viscose or Polyester 100% non-woven fleece, aluminium vaporised

Layer 2: Viscose 100% or  60% + 40% Polyester, non-woven fleece

Layer 3: 100 Viscose or 100% hydrophobic Polypropylene none woven fleece

- The middle layer acts as an absorption cushion

- Absorption capacity : +/- 1.400 g/m2

- Colour: Wound side silvery grey   

- Elastic gauze bandage: width: 6cm wide, fixed on external side (white) top and bottom, to secure dressing in place 

Unit presentation:

1 aluminised compress/pad, sterile, single use, in peel packed sachet

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.

Secondary packaging:

Labelling to be the same as primary packaging.

Extra information required: Number of units

Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate

Over packaging:

Packaging unit: Strong carton board

Other requirements:

Comply with European Medical Device Directive 93/42/EEC 

For MDREFAIDA4:  Non-adherent wound dressing, sterile, Class IIb