Draeger Jaundice Meter JM-105

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

DRAEGER SINGAPORE PTE LTD

class:

Class B medical device

manufactured_by:

Draeger Medical Systems, Inc.

therapeutic_area:

Obstetrics & Gynaecology

therapeutic_indication:

Jaundice Meter is non-invasive transcutaeous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The Jaundice Meter is indicated for use in neonatal patients born ≥24 weeks gestation who have not undergone exchange transfusion. The device is indicated only for use before, during, and after phototherapy treatment. The device is intended for use in hospitals or doctors offices under a physician's supervision, or at their direction. It helps clinicians to monitor newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device with other clinical signs and laboratory measurements.

leaflet_short:

Models: Jaundice Meter JM-105 - MU20105, Jaundice Meter JM-105 - MU24768, Jaundice Meter JM-105 - MU24771, Docking Station JM-A33 for JM-105 - MU24805, USB Cable - MU24774, Data Transmission Software - MU24775, AC Adapter JM-105/JM-103 - MU19792

authorization_date:

2014-09-17