Duns Number:053146767
Device Description: Adult Adapter - 15mm ID/22mm OD x15mm ID/22mm OD. Fits components of adult ventilator circ Adult Adapter - 15mm ID/22mm OD x15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
Catalog Number
KC 105
Brand Name
KC 105 Adapter
Version/Model Number
KC 105
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
-
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
ea79b68a-1789-4c42-a8c9-32d97e20d720
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
July 21, 2017
Package DI Number
M996KC1052
Quantity per Package
10
Contains DI Package
M996KC1050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| 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 |