Duns Number:038000253
Device Description: 11.5F X 15CM SOFT-LINE® DUO-FLOW®IJ CATHETER W/2 SUTURE WINGSW/2 SUTURE WINGS
Catalog Number
DT116IJC-2
Brand Name
SOFT-LINE®DUO-FLOW®IJ
Version/Model Number
DT116IJC-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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
3675ea9e-89d6-4787-b110-7ef7c3f90534
Public Version Date
July 13, 2021
Public Version Number
3
DI Record Publish Date
July 18, 2019
Package DI Number
50884908146177
Quantity per Package
10
Contains DI Package
00884908146172
Package Discontinue Date
June 30, 2021
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 |