VERIFY SixCess

Basic Information

• Brand Name: VERIFY SixCess
• Primary DI: 00724995218560
• Version / Model: LCC019
• Catalog Number: LCC019
• Company Name: STERIS CORPORATION
• Labeler DUNS: 868205779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-07
• Public Version: 1
• Public Version Date: 2022-11-15
• Public Version Status: New
• Public Device Record Key: fe90aca2-492d-4f24-9a2a-f90805870273

Device Description

The VERIFY SixCess 270FP Challenge Packs are designed for process challenge testing of steam sterilizers using standard and extended cycles.

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
JOJ	Indicator, physical/chemical 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
Package	10724995218567	GS1	Box	20	In Commercial Distribution
Primary	00724995218560	GS1
Previous	10724995091146	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103053	000
K162758	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct light
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit