DeviceClearance

K253322

Substantially Equivalent

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

Applicant
Medline Industries, LP
Product code
BZE
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Northfiled, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE
Death
4
Malfunction
910
Other
1
Total
915

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.