Hyperinflation Kit, 1L

Dénomination commerciale

Hyperinflation Kit, 1L

04710810112409

471081008NNRRAE

Numéro de référence/catalogue

AB0157

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Single patient use flow-inflating bag for use in hospital and transport to temporarily ventilate neonate, infant and pediatric patients.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 1

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

• 04710810112409× 1 unitéUnité de base
  • 44710810112407× 20 unités

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

• R02010101BREATHING CIRCUITS, W/O WATER TRAP

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

• Consulter la notice d’utilisation

  " Intended for use by qualified personnel trained in advanced pulmonary ventilation.  Always test this product for proper function before use on a patient.  Proficiency in the use of this product must be demonstrated before use on a patient. Unfollow the direction of testing before use, common case as below:  Oxygen tubing kinked- Unable to deliver oxygen.  Unstable pressure of spring valve or relief valve failure- Higher output pressure to patients- Barotrauma  The Single Patient Use product does not contain any items that can be reprocessed. Not intended to reprocess since it may result in harmful substances entering the human body through the airway.  Pressure monitored by attaching the manometer to the Hyperinflation Kit ensures a safe range.  Do not administer supplemental oxygen in the presence of fire, spark, or open flame.  Do not use oil, grease, or any hydrocarbon-based substance on any part of the product.  Do not use it in a toxic environment.  If obvious damage or dirt is found on the product inside the package, DO NOT use the device.  Mask sealing extent with the face affects the treatment for the patients."