21.401

Nom de l'organisation

XVIVO B.V.

SRN

NL-MF-000018307

Statut du fabricant

—

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

• CW007

  The product is sterile in the unopened and undamaged packaging. Carefully inspect the product for breaches of the integrity of the packaging. Do not use if the packaging or Kidney Assist Perfusion Set is damaged, or even if there is the slightest doubt regarding the sterility of the product.
• CW032

  Check the expiry date on the Kidney Assist Perfusion Set. Do not use if the date has expired.
• CW009

  The Kidney Assist Perfusion Set is for single use only and may not be re-used or re-sterilized.
• CW999

  XVIVO is not responsible for any damage caused operating the device outside the intended use.
• CW999

  Modifications, especially post-treatments of the Kidney Assist Perfusion Set is not allowed; they would affect safety and lead to exclusion of liability.
• CW999

  Please contact XVIVO directly with any complaint at: qa.xnl@xvivogroup.com
• CW999

  Safe use of the Kidney Assist can only be guaranteed when the operator is a skilled and trained professional and has successfully followed a Kidney Assist training course.
• CW999

  Any serious incident that has occurred in relation to Kidney Assist should be reported to XVIVO and the competent authority of the Member State in which the user and/or patient is established.
• CW999

  Do not tap the oxygenator and pump head with hard tools during priming procedure.

Marché principal en Pays-Bas ; disponible dans 10 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08719925460722

Basic UDI-DI

871992546400MH

Numéro de référence/catalogue

21.401

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

For oxygenated hypothermic and normothermic perfusion of donor kidneys.

URL des informations complémentaires

https://www.xvivogroup.com/resource-type/instructions-for-use/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• 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.

• C0399CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER