Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

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

Classification

FDA Product Code: QTI
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

Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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