Duns Number:038000253
Device Description: 11.5F X 15CM Tri-Flow IJ CATHETER ONLY
Catalog Number
-
Brand Name
Tri-Flow
Version/Model Number
XTP3116CTPC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 20, 2022
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
ec093d2e-84a3-4031-acc4-f0a926fdaedd
Public Version Date
June 24, 2022
Public Version Number
6
DI Record Publish Date
October 23, 2015
Package DI Number
50884908060497
Quantity per Package
10
Contains DI Package
00884908060492
Package Discontinue Date
June 20, 2022
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |