PEF — Heparin Flush In 0.45% Sodium Chloride Class II
FDA product code PEF covers "Heparin Flush In 0.45% Sodium Chloride", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- PEF
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.