Identity
- Trade Name
- Nephros DSU-H UltraFilter FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- The Nephros DSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid 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. FDA UDI
- Model / Reference
- 70-0286 FDA UDI
- Description
- The Nephros DSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896241002374 FDA UDI
- 510(k) Number
- K141731 FDA UDI
- FDA Product Code
- NHV FDA UDI
- GMDN Term
- Microbial water purification filter, non-sterilizable 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
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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: Microbial water purification filter, non-sterilizable
Nephros DSU-H UltraFilter by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141731 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 9e0f08dc-e226-4862-9d9b-b30fc4bc55f6 35 fields · synced Jun 8, 2026