Sinapi Chest Drain

Dénomination commerciale

Sinapi Chest Drain

06009888639382

60099003867SCDW5

Numéro de référence/catalogue

XS50-D

GS1

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The SINAPI Chest Drain (SCD) is a non-invasive medical device that is connected to any inserted chest catheter. It is a sterile, single use device, intended to drain fluid from the thoracic cavity.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

1 niveau de conditionnement enregistré — chaque niveau porte son propre IUD-ID.

• 06009888639382× 1 unitéUnité de base
  • 16009888639389× 10 unités

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

• A060203PLEURAL DRAINAGES WITH VALVE AND KITS

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

• Avertissement

  1. This device is only intended for use by appropriately trained personnel, familiar with thoracic surgical procedures and techniques, including chest drain use. 2. Do not use device in situations that require active suction in the pleural space. 3. Compatibility of the Sinapi Chest Drain with thoracic catheters needs to be established by the user. 4. Regularly assess the thoracic catheter connections for signs of an air leak. 5. Replace the XS50 chest drain if it is damaged or if there is evidence of occlusion. 6. Connect only ONE chest catheter per chest drain. 7. Do not clamp tube, this will inhibit drain operation and may compromise respiratory function of patient. 8. The needle-free sampling port located on the front of the device can also be used to drain fluid from the collection reservoir. 9. Observing Universal Precautions, discard the SCD in a medical waste container, in accordance with the Waste Management policy of the health care facility. 10. NOTE: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

• Ne pas restériliser

  Do not resterilize

• Ne pas réutiliser

  Single use only

• Ne pas utiliser si l’emballage est endommagé

  Do not use if package is damaged