Duns Number:053146767
Device Description: General Adapter 10mm OD x 10mm OD. Fits components of neonatal ventilator circuits/CPAP sy
Catalog Number
KC 1010
Brand Name
KC 1010 Adapter
Version/Model Number
KC 1010
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
e0f1fe26-ad8d-499e-a6c7-aa4176ec34cd
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
July 21, 2017
Package DI Number
M996KC10106
Quantity per Package
100
Contains DI Package
M996KC10100
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 |