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

Label Or Tag, Non-Sterile

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

QMX is the FDA product code for Label Or Tag, Non-Sterile, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QMX
Device name
Label Or Tag, Non-Sterile
FDA definition
The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products.
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
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