STERIZONE® BI+ Self-contained Biological Indicator 42602-1

GUDID 00690455426021

The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.

TSO3 Inc

Biological sterilization indicator

• Primary Device ID: 00690455426021
• NIH Device Record Key: 3640e5fd-4107-408f-b7bf-da8983631da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIZONE® BI+ Self-contained Biological Indicator
• Version Model Number: 42602-1
• Catalog Number: 42602-1
• Company DUNS: 256900895
• Company Name: TSO3 Inc
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690455426021 [Primary]
GS1	00690455750218 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141580

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

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: 2018-07-06The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
• 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: 2018-07-06 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