STERIZONE® BI+ Self-contained Biological Indicator

Basic Information

• Brand Name: STERIZONE® BI+ Self-contained Biological Indicator
• Primary DI: 00690455426021
• Version / Model: 42602-1
• Catalog Number: 42602-1
• Company Name: TSO3 Inc
• Labeler DUNS: 256900895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: 3640e5fd-4107-408f-b7bf-da8983631da3

Device Description

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.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRC	Indicator, Biological Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690455426021	GS1
Unit of Use	00690455750218	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141580	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius