Duns Number:240623124
Device Description: 10" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a 10" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a male swivel luer lock connector on the one end and female luer lock connector on the other. A small pinch clamp is also provided on each tube segment. Protective caps are secured to each end to prevent product contamination and maintain sterility when the sterile pouch is opened.
Catalog Number
17-088
Brand Name
10" Dialysis Tubing Extensions (Pair)
Version/Model Number
1.5
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K833112,K833112
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
0a39fc30-5bf0-42e0-a0a5-604c9c73e180
Public Version Date
April 16, 2020
Public Version Number
1
DI Record Publish Date
April 08, 2020
Package DI Number
36641670000836
Quantity per Package
50
Contains DI Package
16641670000825
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |