Identity
- Trade Name
- TQE Plus Endotoxin 10" Filter Flat 222 Head FDA UDI
- Generic Name
- Peritoneal dialysis system dialysate filter FDA UDI
- Device Name
- The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. FDA UDI
- Model / Reference
- TQE0.005-10P3E FDA UDI
- Description
- The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868277000419 FDA UDI
- 510(k) Number
- K161304 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Peritoneal dialysis system dialysate 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
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
Liquid Chemical FDA UDI
TQE Plus Endotoxin 10" Filter Flat 222 Head by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K161304 also covers:
- Filtro de Endotoxina Nephros EndoPur (plano) 10" — NEPHROS, INC.
- Filtro de Endotoxina Nephros EndoPur (plano) 20" — NEPHROS, INC.
- Nephros EndoPur Endotoxin 10” Filter — NEPHROS, INC.
- Nephros EndoPur Endotoxin 20” Filter Flat — NEPHROS, INC.
- TQE Plus Endotoxin 10" Filter Flat 222 Head — NEPHROS, INC.
- TQE Plus Endotoxin 20" Filter Flat 222 Head — 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 fbeb2ecb-ae47-4bcd-b198-062e1cd527b6 35 fields · synced Jun 8, 2026