Duns Number:053146767
Device Description: KC 10 Tubing Separator separates large bore tubing from small bore tubing. Made of silicon KC 10 Tubing Separator separates large bore tubing from small bore tubing. Made of silicone rubber. Reusable. Made in the USA.
Catalog Number
KC 10
Brand Name
KC 10 Tubing Separator
Version/Model Number
KC 10
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
1d4b435f-6bfe-401b-bbe5-03051341d80f
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
May 31, 2019
Package DI Number
M996KC106
Quantity per Package
100
Contains DI Package
M996KC100
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 |