VivereX™

Nom de l'organisation

Sunmedic AB

SRN

SE-MF-000012997

Statut du fabricant

Actif

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

• CW999

  Contraindication: VivereX(+)™ system is contraindicated for: 1. Wounds with malignancy except in palliative care 2. Wounds with untreated osteomyelitis 3. Wounds with untreated non-enteric fistula 4. Wounds covered by necrotic tissue 5. Wounds with exposed bone, blood vessels, nerves, organs or anastomotic site 6. Tracheostomy and surgical drains 7. Wounds in patients with known allergies to silicone, nylon or acrylic glue 8. For aspiration or suction purpose beyond those specified in the indications for use For detailed Warnings, see the Product IFU.

Marché principal en Suède ; disponible dans 23 pays au total.

Dénomination commerciale

VivereX™

Code d'UDI-DI

17350127832276

Basic UDI-DI

B-17350127832276

Numéro de référence/catalogue

PDI600227

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

VivereX™ Dressing is medical therapeutic device which manages infiltrate excess wound exudate of a wound through combination of absorption through is superabsorbent layer and vaporization of moisture via cover layer. VivereX™ Dressing is suitable for use at both hospitals and home care settings. Appropriate wound types include: Acute wounds, Chronic wounds with small or medium secretion, Skin grafts or flaps, Pressure ulcers, Diabetic ulcers, surgically clean and closed incisions, Subacute dehisced wounds, Trauma wounds, and Burn injury grade I and II. The VivereX™ dressing manages the wound exudate by two different mechanisms: The absorbent layer of the dressing absorbs some of the secretion. The dressing allows evaporation of the rest of the wound secretion.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• VivereX™ Dressing FC 21x21

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

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• M04040702SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES