Device Dossier
Blanket/pad infant phototherapy unit
Device Dossier for Blanket/pad infant phototherapy unit (Blanket/pad infant phototherapy unit, Class IIa, sponsor GE Healthcare). ARTG record, intended…
- GMDN category: Blanket/pad infant phototherapy unit
- Sponsor: GE Healthcare
Intended purpose
This phototherapy device is intended to be used for the treatment of indirect hyper-bilirubinemia in term and pre-term infants, in a hospital environment ± NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. This device is intended for use under the direct supervision of a licensed healthcare practitioner.