Duns Number:012983893
Device Description: All 'n One Securement for Large Luer Lock or Block
Catalog Number
PCS-1012
Brand Name
Clik-FIX
Version/Model Number
PCS-1012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 30, 2018
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
d21d61cf-2894-443e-b771-094733cf78e7
Public Version Date
July 22, 2019
Public Version Number
9
DI Record Publish Date
March 16, 2017
Package DI Number
10850933007181
Quantity per Package
50
Contains DI Package
00850933007184
Package Discontinue Date
August 15, 2017
Package Status
Not in Commercial Distribution
Package Type
-
| 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 |