STERIZONE® VP4 Sterilizer

Basic Information

• Brand Name: STERIZONE® VP4 Sterilizer
• Primary DI: 00690455440003
• Version / Model: 44000-R
• Catalog Number: 44000-R
• Company Name: TSO3 Inc
• Labeler DUNS: 256900895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4d389528-7028-443b-a04f-2129d3efbf99

Device 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJJ	Two Or More Sterilant Sterilizer	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56749	Ozone/hydrogen peroxide sterilizer	A mains electricity (AC-powered) device designed for terminal sterilization and/or inactivation of microorganisms from medical devices and related products using a combination of vaporized hydrogen peroxide (H2O2) and ozone gas as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available as a stand-alone (bulk) unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690455440003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153392	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 26 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 35 – 80 Percent (%) Relative Humidity