Duns Number:053146767
Device Description: The KC 00.5N-2P is a 1/2-liter neoprene reservoir bag intended to store breathing gas duri The KC 00.5N-2P is a 1/2-liter neoprene reservoir bag intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. This is a single-use device.
Catalog Number
KC 00.5N-2P
Brand Name
KC 00.5N-2P 1/2-liter reservoir bag
Version/Model Number
KC 00.5N-2P
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
BTC
Product Code Name
Bag, Reservoir
Public Device Record Key
dc4e5a06-ca17-41b2-933c-e059a9fd4907
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 31, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |