FIZE kUO Console

FDA UDI

Class II (US FDA UDI)

by Fize Research Ltd

Identity

Trade Name: FIZE kUO Console FDA UDI
Generic Name: Urine monitoring system FDA UDI
Device Name: FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US FDA UDI
Model / Reference: 5G2 FDA UDI
Description: FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US FDA UDI

Identifiers

Catalog Number: FI-FG00-KU00-0006 FDA UDI
Primary DI / UDI-DI: 07290019239031 FDA UDI
FDA Product Code: EXY FDA UDI
GMDN Term: Urine monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1800 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Urine monitoring system

FIZE kUO Console by Fize Research Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Sensica UO System — C. R. Bard, Inc. · Class II
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Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II

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: Fize Research Ltd

Sources (1)

FDA UDI e907d61b-f36d-44a3-9c64-579d49c7c454 34 fields · synced May 30, 2026