Duns Number:038000253
Device Description: 15.5F X 28CM T-3 TRIPLE LUMEN CT FULL TRAY
Catalog Number
-
Brand Name
T3 TRIPLE LUMEN
Version/Model Number
MC013524
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2020
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
44ce830f-3a1a-44d3-9944-5c8c5a69d3ac
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
March 02, 2016
Package DI Number
50884908092726
Quantity per Package
5
Contains DI Package
00884908092721
Package Discontinue Date
June 24, 2020
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 |