SYSTEM 1 endo Liquid Chemical Sterilant Processing System

Basic Information

• Brand Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System
• Primary DI: 00724995155728
• Version / Model: endo
• Catalog Number: P6800
• Company Name: Corporation Steris Canada
• Labeler DUNS: 202659140
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-03
• Public Version: 5
• Public Version Date: 2020-09-30
• Public Version Status: Update
• Public Device Record Key: 9096dae6-a089-4727-9a02-81e044f9cc73
• Distribution End Date: 2020-09-30

Device Description

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices.

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: Yes
• 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
MED	Sterilant, medical devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36253	Liquid sterilant sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products by immersion in sterilant solutions [e.g., formaldehyde, glutaraldehyde, ortho-phthalaldehyde (OPA) also known as phthaldehyde]; it is typically used for products sensitive to high temperature and humidity and not damaged by sterilant solution. It typically includes a treatment chamber with a container for liquid sterilant and where trays with the devices to be sterilized are manually placed, usually after cleaning of gross debris; a mechanism to introduce and/or circulate the liquid into the chamber; and controls to regulate procedure time.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995155728	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173256	000
K182827	000
K190104	000
K192929	000