Duns Number:120664557
Device Description: The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids 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 handsContraindications:Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
Catalog Number
-
Brand Name
HydraGuard 10" UltraFilter
Version/Model Number
70-0111
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
e381828d-e908-42e4-a0dc-114a581699ea
Public Version Date
September 17, 2021
Public Version Number
5
DI Record Publish Date
July 19, 2017
Package DI Number
10866318000326
Quantity per Package
1
Contains DI Package
00866318000329
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 |