Identity
- Trade Name
- Nephros HydraGuard 10” UltraFilter – Flush FDA UDI
- Generic Name
- Particulate water purification filter FDA UDI
- Device Name
- Description: The Nephros 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 FDA UDI
- Model / Reference
- 70-0112 FDA UDI
- Description
- Description: The Nephros 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866318000343 FDA UDI
- 510(k) Number
- K161467 FDA UDI
- FDA Product Code
- NHV FDA UDI
- GMDN Term
- Particulate water purification filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Particulate water purification filter
Nephros HydraGuard 10” UltraFilter – Flush by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Particulate water purification filter.
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Cleared under the same submission
K161467 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nephros, Inc.
Sources (1)
- FDA UDI e744af4c-95e0-4c73-b886-29cd4ef377bd 36 fields · synced May 30, 2026