TQE Plus Endotoxin 20" Filter Flat 222 Head

FDA UDI

Class II (US FDA UDI)

by Nephros, Inc.

Identity

Trade Name: TQE Plus Endotoxin 20" Filter Flat 222 Head FDA UDI
Generic Name: Haemodialysis system dialysate pyrogen 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: TQE0.005-20HP3E 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: 00868277000457 FDA UDI
510(k) Number: K161304 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Haemodialysis system dialysate pyrogen filter 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Haemodialysis system dialysate pyrogen filter

TQE Plus Endotoxin 20" Filter Flat 222 Head by Nephros, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system dialysate pyrogen filter.

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Diasafe — Fresenius Medical Care · Class II
DIASAFE®plusUS — Fresenius Medical Care Renal Therapies Group, LLC · Class II
MarCor ENX Hollow Fiber Capsule UltraFilter — NEPHROS, INC. · Class II
TQE Plus Endotoxin 10" Filter Flat 222 Head — NEPHROS, INC. · Class II
Nephros SSUmini JG UltraFiltro — NEPHROS, INC. · Class II

Cleared under the same submission

K161304 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 0f3ca494-8b4e-4566-8bc3-213cfc60a5f7 34 fields · synced May 30, 2026