VESSILEN KIT

Dénomination commerciale

VESSILEN KIT

08031359062106

8031359VKIT55

Numéro de référence/catalogue

6210

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

MODALITÀ D’USO: 1 instillazione endo-vescicale ogni 7 giorni o secondo altra indicazione del medico. ISTRUZIONI PER L’USO: Si raccomanda di manipolare i dispositivi che compongono Vessilen® kit solo dopo aver lavato accuratamente le mani e di adottare tutte le precauzioni possibili al fine di ridurre il rischio di contaminazione del prodotto. Attendere lo svuotamento spontaneo della vescica, inserire in vescica un catetere sterile ed attendere il completo svuotamento della vescica. Prelevare la soluzione sterile dal flacone in vetro con la siringa e l’ago sterili monouso forniti. Rimuovere l’ago dalla siringa. Collegare alla siringa l’adattatore Luer-Lock sterile e monouso fornito. Connettere l’adattatore Luer-Lock al catetere ed instillare nella vescica tutta la soluzione contenuta nella siringa.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• U1302KITS FOR BLADDER WASHING AND INSTILLATION

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

• Instillation with Vessilen® kit should be performed by competent medical personnel using the sterile medical devices inside the package (syringe, needle and Luer-Lock adapter). Vessilen® kit is intended for a single procedure. Do not re-sterilize. Do not reuse unused portions of solution, do not reuse the syringe, needle or Luer-Lock adapter. Do not use if the packaging is open and/or damaged as the sterility of the devices in the kit is compromised. Re-use of the kit components may pose a risk of patient contamination. No side effects are known from the use of Vessilen® 50 ml when used as indicated by the Manufacturer. Currently, there are no known interactions between Vessilen® 50 ml and medicines normally used in the related pathologies. The product is not indicated for subjects already sensitized to components present in the formulation. Discontinue treatment if any adverse effects occur. Keep out of sight and reach of children. Do not use after the expiry date. Dispose of the kit components in accordance with current regulations.

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