Duns Number:038000253
Device Description: 13F X 12CM DUO-SPLIT® IJ CATHETER BASIC SETIJ CATHETER
Catalog Number
DDSP134PS
Brand Name
DUO-FLOW®
Version/Model Number
DDSP134PS
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
f0596bb3-8d50-4b47-a13f-eabb1b8622b1
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 02, 2019
Package DI Number
50884908144272
Quantity per Package
5
Contains DI Package
00884908144277
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 |