Administration Set Docking Station

ODI · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440

Classification

FDA Product Code: ODI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5440
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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