MorbideX® – Protective cushion Adult

Nom de l'organisation

BenCorpp Srl

SRN

IT-MF-000023046

Statut du fabricant

Actif

Santé des certificats sur le portefeuille de ce fabricant.

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  Wash your hands and clean your face carefully before applying MorbideX®. Gently place MorbideX® on the nasal bridge and cheekbones. Then place the CPAP and BIPAP mask over MorbideX® for a comfortable fit that minimizes leaks. Alternatively, you can apply MorbideX® directly to the edges of the mask before putting it on. Do not use if the device shows any signs of defect. Do not use if the package is opened or damaged.
• CW007

  EUDAMED n'a pas publié de description pour ce code.
• CW011

  Non-sterile, mono-patient reusable product: after each application, wash the device with a neutral detergent and tap water. Keep the device in a ventilated place until the water has evaporated. It is recommended to replace MorbideX® at most every 30 days or after 60 re-uses. Once dry, place MorbideX® back in its packaging until the next use. Store in clean and dry place, at room temperature. Do not use on damaged skin. Do not use the product after the expiration date. The expiry date refers to the intact and correctly stored product. Destroy after use. Always follow medical practice and national requirements regarding biohazards when disposing of a used medical device. In case of undesirable effects, discontinue use, consult your doctor and inform the manufacturer. In the event of serious accidents occurring related to the use of the device MorbideX®, send a report to the manufacturer (info@bencorpp.com), to the Italian Ministry of Health or to the competent authority of the EU Member State in which the product has been used.

Marché principal en Italie ; disponible dans 32 pays au total.

Dénomination commerciale

MorbideX® – Protective cushion Adult

Code d'UDI-DI

08056209010144

Basic UDI-DI

805620901mbxSC

Numéro de référence/catalogue

MBX-01

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

—

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.

• R030180RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES