Heparin Flush In 0.45% Sodium Chloride

PEF · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5200

Classification

FDA Product Code: PEF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5200
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown