Duns Number:120664557
Device Description: The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. Itassists 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 with other water treatment equipment (RO, DI, etc.).
Catalog Number
-
Brand Name
SSUmini JG 3/8
Version/Model Number
70-0251C
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
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
682c8bbe-b456-4e25-a6a4-095683b7679c
Public Version Date
September 14, 2021
Public Version Number
5
DI Record Publish Date
December 31, 2017
Package DI Number
10866318000302
Quantity per Package
24
Contains DI Package
00866318000305
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 |