Identity
- Trade Name
- EndoPur Endotoxin 40" Filter FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 40” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.). FDA UDI
- Model / Reference
- 70-0140 FDA UDI
- Description
- Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 40” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896241002671 FDA UDI
- 510(k) Number
- K110285 FDA UDI
- FDA Product Code
- FIP 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
EndoPur Endotoxin 40" Filter by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K110285 also covers:
- MarCor ENX Hollow Fiber Capsule UltraFilter — NEPHROS, INC.
- Nephros DSU-D UltraFilter — NEPHROS, INC.
- Nephros SSU-D UltraFilter — NEPHROS, INC.
- Nephros SSUmini JG UltraFilter — NEPHROS, INC.
- Nephros SSUmini JG UltraFiltro — NEPHROS, INC.
- Nephros SSUmini UltraFilter — NEPHROS, INC.
- Nephros SSUmini UltraFiltro — NEPHROS, INC.
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 bc686a35-09ef-49d0-99a4-804634d1b4fc 35 fields · synced Jun 6, 2026