Duns Number:053146767
Device Description: The KC 145-2230D Hose Connector: Dimensions - 22mm I.D/30mm O.D. x tapered barb adapter. The KC 145-2230D Hose Connector: Dimensions - 22mm I.D/30mm O.D. x tapered barb adapter. This is a single patient use device
Catalog Number
KC 145-2230D
Brand Name
KC 145-2230D Hose Connector
Version/Model Number
KC 145-2230D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
af2655f5-a035-4cc5-9c40-0e7e738966e5
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
December 16, 2019
Package DI Number
M996KC1452230D6
Quantity per Package
100
Contains DI Package
M996KC1452230D0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock polybag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |