BABY START

Nom de l'organisation

GINEVRI srl

SRN

IT-MF-000034527

Statut du fabricant

Actif

Santé des certificats sur le portefeuille de ce fabricant.

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

• CW010

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

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

Dénomination commerciale

BABY START

Code d'UDI-DI

08053847360112

Basic UDI-DI

B-08053847360112

Numéro de référence/catalogue

7236

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Baby Start is a manual resuscitator suitable for delivery rooms, post-partum, special units for the care of newborns and Neonatal Intensive Care Units. It is a tool to resuscitate asphyxiated newborns using a mask or endotracheal tube. Resuscitation is carried out under positive pressure with manual control and free exhalation. The mixture flows into the lungs at pressures adjustable by the operator. The use of the T-fitting can achieve the desired PIP and determine the constant PEEP to help create FRC and improve lung tidal volume. Resuscitation pressures (PIP and PEEP) are indicated on aneroid bronchomanometer with fast response and easy reading. Above the chosen maximum pressure value (PIP), the built-in "max pressure" safety valve is activated to prevent the danger of excessive inspiratory pressures. The manual control is obtained by obstructing, with a finger, the PEEP valve, placed on the resuscitation head. The mixture flows throughout the duration of the above indicated obstruction. The resuscitator works connected to a source of air, oxygen or mixture of both taken from Flowmeter Mixer or Blender that can be connected to a gas humidifier. The device uses a disposable circuit made with spiral tube complete with expiratory valve and neonatal mask or cannula.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 5 ÷ 15 L/m

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

• R03020201MANUALLY OPERATED PULMONARY RESUSCITATORS