Duns Number:053146767
Device Description: The KC 9-P with removable cap is designed for use on ventilators not equipped with expirat The KC 9-P with removable cap is designed for use on ventilators not equipped with expiratory hold. It allows single breath measurement of auto-PEEP in its use as a Braschi valve.Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution,2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.
Catalog Number
-
Brand Name
KC 9-P Auto-PEEP Measurement Device
Version/Model Number
KC 9-P
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983631,K983631
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
06dbc3e9-802d-421f-a577-3b0c1ba7a12c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 22, 2015
Package DI Number
M996KC9P2
Quantity per Package
10
Contains DI Package
M996KC9P0
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 |