FOC

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bag, Urine Collection, Newborn

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5250

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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