inforMED
OJAClass II

Intravenous Extension Tubing Set

General Hospital · 21 CFR 880.5440

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events39All time
Recalls4All time
Registered firms31Currently listed
510(k) clearances1All time

Recalls

4 recall events for this product code

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