Device typeMedical product temperature point indicator, thermochemical: A small device intended to be attached to a bag containing a temperature-sensitive medical product (e.g., blood, pharmaceutical) to indicate, by non-reversible chemical colour change, when a predetermined temperature is reached and exceeded, potentially making the product non-viable. It typically consists of a self-adhesive plastic container that holds a patch of heat-sensitive material which is activated when the container is attached to the product of interest. This is a single-use device.
FDA categoryIndicator, Physical/Chemical Sterilization Process
Device ID00852282007129
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information