Duns Number:827716437
Device Description: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry.SP-015V50 unit box contains 50 SP-015V applicators
Catalog Number
SP-015V50
Brand Name
SecurePortIV
Version/Model Number
SP-015V50
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
K170505,K170505
Product Code
NZP
Product Code Name
Sealant, Microbial
Public Device Record Key
fb0d680f-c9c8-4cbd-a440-23df02164776
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
April 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |