FIZE kUO Disposable Kit

FDA UDI

Class II (US FDA UDI)

by Fize Research Ltd

Identity

Trade Name: FIZE kUO Disposable Kit FDA UDI
Generic Name: Urine monitoring system FDA UDI
Device Name: FIZE kUO Disposable Kit Catalog number for 1 pc: FI-KT00-KU01-0001 Catalog number for 10 pcs in box: FI-FG00-KU03-0001 FDA UDI
Model / Reference: G1 FDA UDI
Description: FIZE kUO Disposable Kit Catalog number for 1 pc: FI-KT00-KU01-0001 Catalog number for 10 pcs in box: FI-FG00-KU03-0001 FDA UDI

Identifiers

Catalog Number: FI-KT00-KU01-0001 FDA UDI
Primary DI / UDI-DI: 07290019239246 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Urine monitoring system

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

Similar devices

Also classified as Urine monitoring system.

Sensica UO System — C. R. Bard, Inc. · Class II
Sensica UO System — C. R. Bard, Inc. · Class II
Sensica UO System — C. R. Bard, Inc. · Class II
Sensica UO System — C. R. Bard, Inc. · Class II
Bard® Uros™ Precision Urine Output and Temperature Monitor — C. R. Bard, Inc. · Class II
Bard® Extension Cable — C. R. Bard, Inc. · Class II
Bard® CritiCore® Collection Container — C. R. Bard, Inc. · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fize Research Ltd

Sources (1)

FDA UDI 91a4d160-24b4-41b1-930b-35834dfbfa6e 34 fields · synced Jun 8, 2026