Duns Number:038000253
Device Description: 9F X 12CM RAULERSON9F X 12CM RAU DUO-FLOW®IJ DOUBLE LUMEN CATHETERCATHETER
Catalog Number
DXTP94IJC
Brand Name
DUO-FLOW®
Version/Model Number
DXTP94IJC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 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
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
d149621a-48e6-4383-a34b-664eb50b9740
Public Version Date
May 12, 2022
Public Version Number
3
DI Record Publish Date
August 16, 2019
Package DI Number
50884908145736
Quantity per Package
10
Contains DI Package
00884908145731
Package Discontinue Date
April 28, 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 |