VS-2

Dénomination commerciale

VS-2

05430001718331

5430001718BF13000545M5

Numéro de référence/catalogue

VS-2

GS1

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Vital Signs is a prescription Procedure Pack that is intended to remote monitor a patient whose vital signs should be sent to a supervising healthcare professional. Vital Signs bundles a number of medical devices and accessories that are used as intended. Specifically, the main components are a Byteflies Kit Model 2, vital sign and health parameter measuring devices (such as body weight scale, blood pressure cuff, body thermometer, and oxygen saturation monitor), a wifi router, compatible ECG and EEG electrodes, and Vital Signs Pro software. The Byteflies Kit Model 2 is used to transmit the measured vital signs and health parameters from the patient's home to the hospital or other healthcare provider. The data can be imported into, and visualized in compatible medical record systems. The recorded data can be organized by the Vital Signs Pro software and made available to the healthcare professional for all enrolled patients in their care. Vital Signs does not extend or modify the intended use of the included components, it simply bundles them in a user friendly package. Any diagnostic decisions based on data collected by Vital Signs are made by a healthcare professional.

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.

• Z12030299VITAL SIGNS MONITORING INSTRUMENTS - OTHER