Duns Number:809699023
Device Description: Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Cathete Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Non-Filled Suture Holes)
Catalog Number
-
Brand Name
Smart Port CT
Version/Model Number
CT80STPD-NF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K062414
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
ea3042fc-9d6c-4b4f-8f36-549681e6e0a5
Public Version Date
July 27, 2020
Public Version Number
5
DI Record Publish Date
September 17, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |