S40

Basic Information

• Brand Name: S40
• Primary DI: 00724995090722
• Version / Model: S4000
• Catalog Number: S4000
• Company Name: STERIS CORPORATION
• Labeler DUNS: 828222781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 9
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 64409ede-55eb-4a3a-b456-9c929fd3b8cd

Device Description

The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

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
MED	Sterilant, medical devices	General Hospital	880.6885	2
FEB	Accessories, cleaning, for endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40580	Organic peroxy acid device sterilant, single-use	A substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995090729	GS1	Case	20	In Commercial Distribution
Primary	00724995090722	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090036	000
K101409	000
K102462	000
K113520	000
K131078	000
K161683	000
K170956	000
K173256	000
K180342	000
K182827	000
K190104	000
K191343	000
K192929	000
K210737	000
K211607	000
K222615	000
K230930	000
K232914	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 16 – 27 Degrees Celsius