[Intended use]:

Sterile Foam Dressing is made from Polyurethane and has good absorbing property, which can be used to cover intubated wounds as well as to help to fix different kinds of cannulas. It can be used as general wound dressing to treat light to moderately exudating wounds: bleeding due to trauma; bleeding surface of a wound and other treatment of skin surface.

[Intended users of the device]:

Laypersons.

[Intended patient population]:

Adults and children.

[Indication]:

The Sterile Hydrocolloid Dressing is used to treat low exudating wounds. It is suitable for debridement of trauma and postoperative wound care.

[Contraindications]:

Used to treat light to moderately exudating wounds: bleeding due to trauma, debridement of trauma and postoperative wound.

[Clinical benefits]:

Ø  Body fluid & blood absorption capacity

Ø  Creates a moist environment.

Ø  Waterproof.

Ø  Soft protect for wound.

[Side effects]:

The product have no known side effects.

[Sterilization]: ETO

[Shelf life]: 3 years.

To apply the wound dressing: 

1.Keep the skin surrounding the wound clean and dry for secure application.

2.Select a dressing of certain specification according to the wound area. The dressing should be larger than 5-10mm than the wound in margins.

3.Open the outer package and pick out the product. Put on the wound smoothly then fix the foam by the help of secondary dressing (no need for AD version).

To remove the wound dressing:    

1. Carefully remove the adhesive layer by lifting one edge and gently peeling the dressing from the skin.

 2. Properly dispose of the dressing.

Warning: Do not reapply after removal

3. Prior to re-dressing, cleanse the wound as directed by a health care professional.

4. Repeat the application procedure outlined above as needed.

[Use warnings]:

Ø  Sterile product, use immediately after open; don’t use in case of broken or opened wrapper;

Ø  Disposable product, reuse is not allowed. Can’t cover the wound for longer than 24H.

Ø  The pad of wound dressing should totally cover the wound, surgical tape can’t contact the wound surface directly;

Ø  3 years of validity, check the expiration date before using, don’t use when the date is expired.

[Storage and transportation]:

1, Store at room temperature, protected from moisture, light, and dust.

2, The device shall be taken care during transportation and handling.

[Contact information]:

Name: Zhejiang Wellong Medical Technology Co., Ltd.

Address: Lvshan Industrial area, Changxing County, 313105 Huzhou, Zhejiang Province, China

Website: www.wellongmedical.com

The authorized representative of European Union:

Name: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg, Germany

Tel: +49-40-2513175

Fax: +49-40-255726

E-mail: shholding@hotmail.com

Contactor: JIN LIANG

Single Registration Number (SRN): DE-AR-000000001