Duns Number:120664557
Device Description: The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used i The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction withother water treatment equipment (RO, DI, etc.).
Catalog Number
-
Brand Name
SSU-D with Orifice
Version/Model Number
70-0243O
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
-
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
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
bd7856b3-b18f-480c-851d-071fb6c26b44
Public Version Date
September 14, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10896241002500
Quantity per Package
10
Contains DI Package
00896241002503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |