Identity
- Trade Name
- SSUmini JG FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. 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 (RO, DI, etc.). FDA UDI
- Model / Reference
- 70-0251 FDA UDI
- Description
- The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. 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 (RO, DI, etc.). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896241002596 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
SSUmini JG 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 69e0ab78-ba08-438a-bf9d-fda9df2e44ad 35 fields · synced May 30, 2026