DeviceClearance

Product code ODI— General Hospital

SWABBABLE CAP, MODEL 60205

Classification name
Administration Set Docking Station
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.”

— U.S. Food and Drug Administration, device classification record for product code ODI under 21 CFR 880.5440, via openFDA

Market context for product code ODI

FDA has cleared 1 device under product code ODI, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ODI

Recent clearances under product code ODI

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