Duns Number:120664557
Device Description: The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality dri The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapurewater for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.
Catalog Number
-
Brand Name
SSU-H Thread
Version/Model Number
70-0284
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
K141731,K141731,K141731
Product Code
NHV
Product Code Name
System, Water Purification, General Medical Use
Public Device Record Key
18efd4e5-9eac-4b06-96b2-a16bd2565c3e
Public Version Date
September 24, 2021
Public Version Number
1
DI Record Publish Date
September 16, 2021
Package DI Number
10896241002401
Quantity per Package
1
Contains DI Package
00896241002404
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Filter Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |