STERIZONE® VP4 Sterilizer

FDA UDI

Class II (US FDA UDI)

by Tso3, Inc.

Identity

Trade Name: STERIZONE® VP4 Sterilizer FDA UDI
Generic Name: Ozone/hydrogen peroxide sterilizer FDA UDI
Device Name: The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States FDA UDI
Model / Reference: 44000-R FDA UDI
Description: The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States FDA UDI

Identifiers

Catalog Number: 44000-R FDA UDI
Primary DI / UDI-DI: 00690455440003 FDA UDI
510(k) Number: K153392 FDA UDI
FDA Product Code: PJJ FDA UDI
GMDN Term: Ozone/hydrogen peroxide sterilizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6860 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

FDA UDI

Over-the-Counter

Yes

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: Ozone/hydrogen peroxide sterilizer

STERIZONE® VP4 Sterilizer by Tso3, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153392 also covers:

125-280 Solution™ for STERIZONE VP4 Sterilizer — Tso3, Inc.

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: Tso3, Inc.

Sources (1)

FDA UDI 4d389528-7028-443b-a04f-2129d3efbf99 37 fields · synced Jun 8, 2026