2008® Series Hemodialysis Machines

FDA UDI

Class II (US FDA UDI)

by Fresenius Usa, Inc.

Identity

Trade Name: 2008® Series Hemodialysis Machines FDA UDI
Generic Name: Haemodialysis system, institutional/home-use FDA UDI
Device Name: 2008K@HOME HEMODIALYSIS SYSTEM FDA UDI
Model / Reference: 190828 FDA UDI
Description: 2008K@HOME HEMODIALYSIS SYSTEM FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861100941 FDA UDI
510(k) Number: K070049 FDA UDI
K150708 FDA UDI
FDA Product Code: ONW FDA UDI
GMDN Term: Haemodialysis system, institutional/home-use 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines by Fresenius Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system, institutional/home-use.

NXVIEW TOUCH SCREEN — NxStage Medical, Inc. · Class II
NXSTAGE SYSTEM ONE PLUS — NxStage Medical, Inc. · Class II
NXView Touch Monitor — NxStage Medical, Inc. · Class II
Moda-flx Hemodialysis System — Diality, Inc. · Class II
NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II
NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II
Moda-flx Hemodialysis System — Diality, Inc. · Class II
Moda-flx Hemodialysis System — Diality, Inc. · Class II

Cleared under the same submission

K070049 also covers:

CombiSet — Fresenius Medical Care Holdings, Inc.

K150708 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: Fresenius Usa, Inc.

Sources (1)

FDA UDI ba624e74-0747-4a83-b6e1-3640f558bc29 35 fields · synced May 30, 2026