MedibinoNEO ring – TG PUR Gel, outer material biocompatible PU film - Size L - PU 6

Nom de l'organisation

Kluba Medical GmbH

SRN

DE-MF-000005421

Statut du fabricant

Actif

Marché principal en Allemagne ; disponible dans 2 pays au total.

Dénomination commerciale

MedibinoNEO ring – TG PUR Gel, outer material biocompatible PU film - Size L - PU 6

Code d'UDI-DI

04260764840557

Basic UDI-DI

4260764840002XQ

Numéro de référence/catalogue

24021703-L

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

6

Description complémentaire du produit

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 2000–60000 MU24

• V028099NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER

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