Filter for dialysate purification

FDA UDI

Class II (US FDA UDI)

by Nikkiso Co., Ltd.

Identity

Trade Name: Filter for dialysate purification FDA UDI
Generic Name: Haemodialysis system dialysate pyrogen filter FDA UDI
Device Name: The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section. FDA UDI
Model / Reference: EF-02D FDA UDI
Description: The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987671030214 FDA UDI
510(k) Number: K152938 FDA UDI
K242155 FDA UDI
FDA Product Code: KDI FDA UDI
GMDN Term: Haemodialysis system dialysate pyrogen filter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

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

Yes

FDA UDI

Category: Haemodialysis system dialysate pyrogen filter

Filter for dialysate purification by Nikkiso Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152938 also covers:

HEMODIALYSIS DELIVERY SYSTEM — NIKKISO CO., LTD.

K242155 also covers:

Hemodialysis Delivery System — NIKKISO CO., LTD.

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: Nikkiso Co., Ltd.

Sources (1)

FDA UDI f5955818-0a4c-46e4-8f54-13b4fc249916 36 fields · synced May 30, 2026