STERIZONE® VP4 Sterilizer 44000-R

GUDID 00690455440003

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

TSO3 Inc

Ozone/hydrogen peroxide sterilizer

• Primary Device ID: 00690455440003
• NIH Device Record Key: 4d389528-7028-443b-a04f-2129d3efbf99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIZONE® VP4 Sterilizer
• Version Model Number: 44000-R
• Catalog Number: 44000-R
• Company DUNS: 256900895
• Company Name: TSO3 Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-866-715-0003
• Email: info@tso3.com
• Phone: 1-866-715-0003
• Email: info@tso3.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690455440003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153392

FDA Product Code

• PJJ: Two Or More Sterilant Sterilizer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

Devices Manufactured by TSO3 Inc

• 00690455426021 - STERIZONE® BI+ Self-contained Biological Indicator: 2018-07-06 The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor int
• 00690455438109 - STERIZONE® CI+ Chemical indicator: 2018-07-06 The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and
• 00690455440003 - STERIZONE® VP4 Sterilizer: 2018-07-06The 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
• 00690455440003 - STERIZONE® VP4 Sterilizer: 2018-07-06 The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of
• 00690455045604 - 125-280 Solution™ for STERIZONE VP4 Sterilizer: 2018-07-06 The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active
• 00690455440201 - STERIZONE® VP4 Test Pack Kit: 2018-07-06 Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor