Duns Number:012983893
Device Description: IV Start Kit with Clik-FIX Universal Hub Securement
Catalog Number
LLSK-1024
Brand Name
Clik-FIX
Version/Model Number
LLSK-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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
5bd07e4a-9f01-4428-b099-3541d256e314
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
March 08, 2019
Package DI Number
20850933007201
Quantity per Package
50
Contains DI Package
10850933007204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |