1250.1

Nom de l'organisation

FARMABAN s.a.

SRN

ES-MF-000004713

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  CONTRAINDICATIONS • Decompensated heart insufficiency • Septic phlebitis • Advanced diabetic microangiopathy • Phlegmasia coerulea dolens • Severe arterial occlusive disease in patients with an ankle-branchial pressure index (ABPI) of less than 0.6 • Known hypersensitivity to any of the materials of the components PRECAUTIONS AND GENERAL CONSIDERATIONS Always apply under the supervision of a healthcare professional. It is recommended to have an adequate training for the correct application of the compression system. Check that the patient’s ABPI is higher than 0.6 before applying the compression system Patients with known arterial insufficiency, decompensated heart insufficiency, or advanced diabetic microangiopathy may not tolerate compression; it should only be used under medical prescription, with careful monitoring and after appropriate treatment. Wrapping too tightly may impair circulation. Monitor the area of application frequently for signs of discolouration, pain, numbness, tingling or other changes in sensation and swelling. If these symptoms appear, patients should remove the bandage immediately and inform the healthcare professional. If the patient does not initially tolerate full compression, the cohesive bandage can also be applied with less tension leading to less compression. Before applying, it is necessary to perform the usual diagnostic examinations. Wounds must be cleansed and covered with wound dressings appropriate to the wound conditions. Follow current national guidelines and local regulations for infections control. If the compression system becomes wet, loose fitting or when it no longer conforms to the shape of the bandaged area it should be replaced. Do not reuse. Reuse can compromise product integrity or lead to device failure. Any serious incident related to the product must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient are established

Marché principal en Espagne ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08428012125016

Basic UDI-DI

8428012COMPRESION2LRZ

Numéro de référence/catalogue

1250.1

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Système de compression à 2 couches

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 10 MU10
• 5.5 MU36
• 18–25 MU10
• 20 MU51

• M03040199ELASTIC COMPRESSION BANDAGES - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel