Duns Number:012983893
Device Description: Neonatal PICC Securement Device with hook and loop
Catalog Number
NPS-1006
Brand Name
Clik-FIX
Version/Model Number
NPS-1006
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
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
3c15e965-b294-40d3-b0e5-7c9a9255109f
Public Version Date
August 25, 2022
Public Version Number
3
DI Record Publish Date
April 18, 2019
Package DI Number
10850933007266
Quantity per Package
50
Contains DI Package
00850933007269
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |