Product code PEF

Device name
Heparin Flush In 0.45% Sodium Chloride
Medical specialty
General Hospital
Device class
2
Regulation number
880.5200
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients.
Source
FDA openFDA device classification dataset