Duns Number:053146767
Device Description: KC 213-D Wye connector with (3) 22mm OD ports. Fits components of adult ventilator circuit KC 213-D Wye connector with (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.
Catalog Number
KC 213-D
Brand Name
KC 213-D 60 degree Angle Wye Connector
Version/Model Number
KC 213-D
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
f1b43474-99cc-4c98-9e7b-9b65731f3ed8
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 11, 2019
Package DI Number
M996KC213D6
Quantity per Package
100
Contains DI Package
M996KC213D0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Heat-sealed 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 |