Duns Number:053146767
Device Description: The KC 5 Pressure Adapter: Dimensions - Luer Lock port x 15mm I.D./22mm O.D. x 15mm O/D The KC 5 Pressure Adapter: Dimensions - Luer Lock port x 15mm I.D./22mm O.D. x 15mm O/D.
Catalog Number
KC 5
Brand Name
KC 5 Pressure Adapter
Version/Model Number
KC 5
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
9d30be0e-9816-4583-b043-af2537796304
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
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 |