Duns Number:120664557
Device Description: The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
Catalog Number
-
Brand Name
S100 Sink Spout
Version/Model Number
70-0280
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
K153084,K153084,K153084
Product Code
NHV
Product Code Name
System, Water Purification, General Medical Use
Public Device Record Key
f3dc538c-be40-4389-a2e6-08503a7f6bd9
Public Version Date
September 24, 2021
Public Version Number
1
DI Record Publish Date
September 16, 2021
Package DI Number
10896241002531
Quantity per Package
1
Contains DI Package
00896241002534
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 |