FDA product code PEF: Heparin Flush In 0.45% Sodium Chloride
PEF is the FDA product code for heparin flush in 0.45% sodium chloride. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. Devices under PEF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Heparin Flush In 0.45% Sodium Chloride |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for PEF devices
openFDA lists no recalls for product code PEF.
Frequently asked questions
What is FDA product code PEF?
PEF is the FDA product code for heparin flush in 0.45% sodium chloride. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is PEF?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PEF
- Run a recall and safety report across every PEF manufacturer
- Watch product code PEF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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