Duns Number:053146767
Device Description: General Adapter 15mm OD x 15mm OD. Fits components of pediatric ventilator circuits/CPAP s General Adapter 15mm OD x 15mm OD. Fits components of pediatric ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
Catalog Number
KC 1515
Brand Name
KC 1515 Adapter
Version/Model Number
KC 1515
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
0bc0a968-319f-4cf6-b229-642812011605
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
July 21, 2017
Package DI Number
M996KC15156
Quantity per Package
100
Contains DI Package
M996KC15150
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 |