Duns Number:038000253
Device Description: 14F X 20CM 400XL W/CURVED EXTENSIONS CATHETER SET
Catalog Number
-
Brand Name
400XL
Version/Model Number
DFXL148CEE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2019
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
6dca59d8-0d16-4026-a02c-9aef073f0ba4
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
April 13, 2016
Package DI Number
50884908098674
Quantity per Package
10
Contains DI Package
00884908098679
Package Discontinue Date
June 07, 2019
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 |