Silicone CPAP Mask

Dénomination commerciale

Silicone CPAP Mask

Code d'IUD-ID

06946430426024

IUD-ID de base

694643043723402Q8

Numéro de référence/catalogue

SCM0101001

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

The Silicone CPAP Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients (>30kg) who have been prescribed CPAP therapy and are under the specific direction of a physician. It is used in conjunction with continuous positive airway pressure devices in home, hospital and institutional environments. The mask is a non-Sterile product only.

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.

• R0301010201CPAP MASKS

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

• CW011

  1. This mask is not suitable for providing life support ventilation. 2. This mask is designed for use with CPAP or Bi-level systems recommended by your healthcare professional or respiratory therapist. 3. Do not wear this mask unless the CPAP or Bi-level system is turned on and operating properly. When the CPAP machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Re-breathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. 4. Do not block or try to seal the exhalation port. 5. If oxygen is used with the device, the oxygen flow must be turned off when the device is not operating.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.