Duns Number:012983893
Device Description: Clik-FIX Securement System for non-cut to length catheters secured with block.
Catalog Number
WCS-1061
Brand Name
Clik-FIX
Version/Model Number
WCS-1061
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
59b4f16a-af47-4042-ac00-463a1913da62
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
January 30, 2017
Package DI Number
10850933007006
Quantity per Package
50
Contains DI Package
00850933007009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |