Device typeIntravenous access site line-disconnection monitoring system: An assembly of noninvasive devices intended to monitor a peripheral intravenous (IV) access site to detect and alert healthcare professionals or a trained dialysis patient to IV line displacement/disconnection (e.g., during haemodialysis). It consists of a portable mains (AC-powered) monitor with display, light source and light sensor, a fibreoptic cable, and may include supportive accessories (e.g., adhesive bandage). A cable tip is affixed near the IV access site and directs light [visible/near infrared (NIR)] to/from the monitor; any blood lost from the access site (extracorpreal blood) is detected and indicative of disconnection.
FDA categoryAutonomous Extracorporeal Blood Leak Detector/Alarm
Device ID07350078030045
Catalog numberRA-1-RA201-C
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
SizeAlarm unit: 128 x 100 x 35 mm
SizeFOE: 2 m long & 15 mm in diametet
SizeUS charger: 55 x 41 x 31 mm, with the cord 3000 mm x 10 mm.
SizeAlarm unit: 150 grams. FOE: 32 grams. US charger: 165 grams.