Duns Number:120664557
Device Description: Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilter that ret Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilter that retains bacteria, viruses, and endotoxin from water.Indications for Use: The HydraGuard 10” UltraFilter - Flush is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is not intended to provide wa
Catalog Number
-
Brand Name
HydraGuard 10" UltraFilter - Flush
Version/Model Number
70-0112
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161467,K161467,K161467
Product Code
NHV
Product Code Name
System, Water Purification, General Medical Use
Public Device Record Key
e744af4c-95e0-4c73-b886-29cd4ef377bd
Public Version Date
September 17, 2021
Public Version Number
5
DI Record Publish Date
December 31, 2017
Package DI Number
20866318000347
Quantity per Package
30
Contains DI Package
10866318000340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |