Duns Number:038000253
Device Description: 12F X 20CM TRI-FLOW12F X 20CM TR TRIPLE LUMEN CATHETER SETTRIPLE W/CURVED EXTENSIONSW/CURV 12F X 20CM TRI-FLOW12F X 20CM TR TRIPLE LUMEN CATHETER SETTRIPLE W/CURVED EXTENSIONSW/CURVED EXTE
Catalog Number
AC0212201
Brand Name
12F TRI-FLOW TRIPLE LUMEN CATHETER12F TRI-FLOW TRIPLE LUMEN CATHETER
Version/Model Number
AC0212201
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
c49fe221-9ee6-478f-8ea5-ea1dbd04ac2f
Public Version Date
November 12, 2018
Public Version Number
1
DI Record Publish Date
October 10, 2018
Package DI Number
50884908131630
Quantity per Package
5
Contains DI Package
00884908131635
Package Discontinue Date
-
Package Status
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 |