STERIZONE® VP4 Test Pack Kit

FDA UDI

Class II (US FDA UDI)

by Tso3, Inc.

Identity

Trade Name: STERIZONE® VP4 Test Pack Kit FDA UDI
Generic Name: Biological sterilization indicator FDA UDI
Device Name: Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor FDA UDI
Model / Reference: 44020 FDA UDI
Description: Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor FDA UDI

Identifiers

Catalog Number: 44020 FDA UDI
Primary DI / UDI-DI: 00690455440201 FDA UDI
510(k) Number: K141580 FDA UDI
FDA Product Code: FRC FDA UDI
GMDN Term: Biological sterilization indicator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2800 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Biological sterilization indicator

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

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Cleared under the same submission

K141580 also covers:

STERIZONE® BI+ Self-contained Biological Indicator — 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 c3e898aa-bf1c-42c5-9f1c-73a8e15bdc1e 36 fields · synced Jun 1, 2026