Duns Number:053146767
Device Description: 90 degree Elbow Connector - 15mm ID/22mm OD x15mm OD. Molded of polystyrene butadiene. S 90 degree Elbow Connector - 15mm ID/22mm OD x15mm OD. Molded of polystyrene butadiene. Single patient use.
Catalog Number
KC 18901-K
Brand Name
KC 18901-K Elbow Connector
Version/Model Number
KC 18901-K
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
-
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
6d6e1a1c-4fc6-4de2-a2e6-f747e40be9e1
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
M996KC18901K5
Quantity per Package
50
Contains DI Package
M996KC18901K0
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 |