QMX — Label Or Tag, Non-Sterile Class I

FDA Device Classification

FDA product code QMX covers "Label Or Tag, Non-Sterile", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
QMX
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products.