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Moda-flx Hemodialysis System

FDA UDI

Class II (US FDA UDI)

by Diality, Inc.

Identity

Trade Name
Moda-flx Hemodialysis System FDA UDI
Generic Name
Haemodialysis system, institutional/home-use FDA UDI
Device Name
Moda-flx Dialysate Generator (DG) device FDA UDI
Model / Reference
101304-001 FDA UDI
Description
Moda-flx Dialysate Generator (DG) device FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00860008016904 FDA UDI
FDA Product Code
KDI FDA UDI
FIP FDA UDI
FJK FDA UDI
GMDN Term
Haemodialysis system, institutional/home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5860 FDA UDI
876.5665 FDA UDI
876.5820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Haemodialysis system, institutional/home-use

Moda-flx Hemodialysis System by Diality, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diality, Inc.

Sources (1)

  • FDA UDI 6475f26a-5105-4f57-8df3-3f693541d457 35 fields · synced May 30, 2026