Duns Number:690542378
Device Description: The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubin The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures.They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System.
Catalog Number
-
Brand Name
BLOOD TUBING LINES FOR HEMODIALYSIS
Version/Model Number
AV06C-P
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"
-
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
KOC
Product Code Name
Accessories, Blood Circuit, Hemodialysis
Public Device Record Key
0d919b91-fdc3-4325-8d7f-e71b28239142
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 2020
Package DI Number
24987671201106
Quantity per Package
28
Contains DI Package
04987671201102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |