Duns Number:053146767
Device Description: Reducing Adapter for use in breathing/ventilator circuit - 15mm ID/22mm OD x 15mm OD. Mold Reducing Adapter for use in breathing/ventilator circuit - 15mm ID/22mm OD x 15mm OD. Molded of polystyrene butadiene. Single Patient Use.
Catalog Number
KC 2119
Brand Name
KC 2119 Reducing Adapter
Version/Model Number
KC 2119
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
f9bb211c-8021-4984-8cb4-a5f9a2ab34da
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
September 08, 2017
Package DI Number
M996KC21196
Quantity per Package
100
Contains DI Package
M996KC21190
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 |