00021500

Nom de l'organisation

HOFFRICHTER GmbH

SRN

DE-MF-000004928

Statut du fabricant

Actif

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• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW011

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Risk of injury due to contraindications! Respiratory therapy may be contraindicated in the case of certain pre-existing conditions. When assessing the relative risks and benefits of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cmH2O. In the event of certain fault conditions, maximum pressure of 40 cmH2O is possible. Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients: • Severe coronary artery disease • Bullous Lung Disease • Pathologically Low Blood Pressure • Bypassed Upper Airway • Pneumothorax • Signs of a sinus or middle ear infection Caution should be used when prescribing CPAP therapy for susceptible patients such as those with: Cerebral Spinal Fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or Pneumothorax. The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Please note: In either case above, it can only be determined by a competent physician whether to use CPAP device. In the presence of contraindications, a doctor should check whether the therapy can still be continued.

Marché principal en France ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04250316302114

Basic UDI-DI

B-04250316302114

Numéro de référence/catalogue

00021500

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The POINT 3 device is used for non-invasive pressure-controlled respiratory support in spontaneously breathing patients. The device is suitable for the treatment of obstructive sleep apnoea in patients with a body weight over 30 kg. The therapy pressure is administered via a breathing mask, which must be equipped with an exhalation valve to ensure the discharge of exhaled air.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12030102CONTINUOUS POSITIVE PRESSURE EQUIPMENT

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