510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PEFClass II

Heparin Flush In 0.45% Sodium Chloride

21 CFR 880.5200 / General Hospital
FDA source (opens on fda.gov)

PEF is the FDA product code for Heparin Flush In 0.45% Sodium Chloride, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PEF
Device name
Heparin Flush In 0.45% Sodium Chloride
FDA 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.
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PEF.