Identity
- Trade Name
- HydraGuard 10” UltraFilter - Flushable FDA UDI
- Generic Name
- Particulate water purification filter FDA UDI
- Device Name
- The HydraGuard 10” UltraFilter - Fin 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 hands Contraindications: Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water. FDA UDI
- Model / Reference
- 70-0111F FDA UDI
- Description
- The HydraGuard 10” UltraFilter - Fin 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 hands Contraindications: Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866318000336 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
- Not 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
HydraGuard 10” UltraFilter - Flushable by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 9ad709d2-0c0b-49af-bbbd-1d5cd8a76719 35 fields · synced Jun 8, 2026