Duns Number:038000253
Device Description: 15.5F X 32CM T-3 TRIPLE15.5F X 3 LUMEN CT (CATHETER ONLY)LUMEN CT
Catalog Number
DMC013545
Brand Name
T-3T-3
Version/Model Number
DMC013545
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 23, 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
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
6189b063-aa47-4805-be08-5eaf912bf0bb
Public Version Date
March 02, 2022
Public Version Number
2
DI Record Publish Date
August 10, 2019
Package DI Number
50884908144104
Quantity per Package
5
Contains DI Package
00884908144109
Package Discontinue Date
February 23, 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 |