125-280 Solution™ for STERIZONE VP4 Sterilizer

FDA UDI

Class II (US FDA UDI)

by Tso3, Inc.

Identity

Trade Name: 125-280 Solution™ for STERIZONE VP4 Sterilizer FDA UDI
Generic Name: Hydrogen peroxide device sterilant FDA UDI
Device Name: The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer FDA UDI
Model / Reference: 44010 FDA UDI
Description: The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer FDA UDI

Identifiers

Catalog Number: 44010 FDA UDI
Primary DI / UDI-DI: 00690455440102 FDA UDI
510(k) Number: K153392 FDA UDI
FDA Product Code: PJJ FDA UDI
GMDN Term: Hydrogen peroxide device sterilant 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hydrogen peroxide device sterilant

125-280 Solution™ for STERIZONE VP4 Sterilizer by Tso3, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Hydrogen peroxide device sterilant.

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Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
VAPROX — STERIS CORPORATION · Class II
Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
SPOROX® II — Sultan Healthcare Inc · Class II
VAPROX — STERIS CORPORATION · Class II
SPOROX® — Sultan Healthcare Inc · Class II

Cleared under the same submission

K153392 also covers:

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 44f8331f-6173-47bc-b6ee-3d4c0c005e7b 37 fields · synced May 30, 2026