Duns Number:038000253
Device Description: 9FX12CM DUO-FLOW® SIDE X SIDE DOUBLE LUMEN CATHETER W/CURVED EXTENSIONS BASIC SET
Catalog Number
AC099121
Brand Name
DUO-FLOW®
Version/Model Number
AC099121
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
MPB
Product Code Name
Catheter, hemodialysis, non-implanted
Public Device Record Key
cd4f6506-8d61-4625-95eb-0c332bd8121c
Public Version Date
February 22, 2021
Public Version Number
1
DI Record Publish Date
February 13, 2021
Package DI Number
50884908136581
Quantity per Package
10
Contains DI Package
00884908136586
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 |