Device Dossier
Pty Ltd - Blanket/pad infant phototherapy unit
Device Dossier for Pty Ltd - Blanket/pad infant phototherapy unit (Blanket/pad infant phototherapy unit, Class IIa, sponsor Paragon Care). ARTG record,…
- GMDN category: Blanket/pad infant phototherapy unit
Intended purpose
The neoBLUE blanket LED Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg).