Duns Number:316150549
Device Description: Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the r Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure.
Catalog Number
955692
Brand Name
THERANOVA
Version/Model Number
500
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
DEN190042,DEN190042
Product Code
QAX
Product Code Name
Hemodialyzer with expanded solute removal profile
Public Device Record Key
2d4c56bd-3165-4668-8128-da4385bdd5fc
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
October 26, 2020
Package DI Number
37332414125722
Quantity per Package
24
Contains DI Package
07332414125721
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. | 23 |