Duns Number:012983893
Device Description: Click-FIX Luer Lock Securement, Pediatric
Catalog Number
LLS-1024
Brand Name
Clik-FIX
Version/Model Number
LLS-1024
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
c5a2d70c-8ca6-4e69-87b3-61b7ee5c4f73
Public Version Date
August 25, 2022
Public Version Number
3
DI Record Publish Date
October 10, 2018
Package DI Number
10850933007259
Quantity per Package
50
Contains DI Package
00850933007252
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 |