Class 1 Device Recall Draeger Jaundice Meter JM105

May 15, 2018· Bilirubin (total and unbound) in the neonate test system - Product Code MQM: Product: Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants.

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[Neonatal jaundice, a diagnostic approach]

Jaundice is a common feature in full-term and premature newborns. Considering this high incidence it is important to distinguish physiologic and non-physiologic jaundice. This differentiation is complicated by the presence of a large overlap between ranges of normal and pathologic bilirubin levels i …


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BiliLux - Draeger

The BiliLux is a compact and lightweight LED phototherapy light system for the treatment of neonatal jaundice. It provides superior phototherapy performance, individualised therapy with electronic documentation capabilities and the flexibility for seamless integration into practically every workplace.

BiliLux - Draeger

The BiliLux phototherapy light was designed for flexible use and seamless integration into the neonatal workplace. The phototherapy light can be placed on an incubator hood, mounted with the spring arm to warming therapy devices or ceiling supplies or used with a trolley. The BiliLux offers the perfect combination for practically every workplace.

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3135 QUARRY RD TELFORD PA 18969 Re: K133175 Trade/Device Name: Jaundice Meter JM-105 Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: I, reserved Product Code: MQM Dated: September 26, 2014 Received: September 26, 2014 Dear Mr. Overton:

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A total jaundice management solution. The Dräger BiliLux Phototherapy light combined with our JM-105 Jaundice meter, provides a complete jaundice management system from screening to therapy. The JM-105 is a non-invasive transcutaneous bilirubinometer that measures the yellowness of subcutaneous tissue in newborn infants as young as 35 weeks ...



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BiliTool is designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns over 35 weeks gestational age. Required values include the age of the child in hours (between 12-146 hours) and the total bilirubin in either US (mg/dl) or SI (µmol/L) units. Two entry options are available.