Duns Number:038000253
Device Description: 15.5F X 32CM T-3 TRIPLE LUMEN CT FULL TRAY
Catalog Number
-
Brand Name
T3 TRIPLE LUMEN
Version/Model Number
MC013525
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 09, 2021
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
273cbb07-291a-44f5-b231-bc254bbf79df
Public Version Date
February 12, 2021
Public Version Number
7
DI Record Publish Date
March 02, 2016
Package DI Number
50884908092733
Quantity per Package
5
Contains DI Package
00884908092738
Package Discontinue Date
February 09, 2021
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 |