Duns Number:012983893
Device Description: Standalone Securement for Large Luer Lock or Block
Catalog Number
ABS-1022
Brand Name
Clik-FIX
Version/Model Number
ABS-1022
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
9415a4a9-a49d-4980-8cbf-6a4f7f356f55
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
March 14, 2017
Package DI Number
10850933007167
Quantity per Package
50
Contains DI Package
00850933007160
Package Discontinue Date
-
Package Status
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 |