EOGas 4 Sterilization Bag

Basic Information

• Brand Name: EOGas 4 Sterilization Bag
• Primary DI: 05060485030416
• Version / Model: AN1004.99
• Catalog Number: AN1004.99
• Company Name: ANDERSEN STERILIZERS INC.
• Labeler DUNS: 931853006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 17
• Record Status: Published
• Publish Date: 2018-09-01
• Public Version: 1
• Public Version Date: 2018-10-02
• Public Version Status: New
• Public Device Record Key: 073c07c0-af6a-4bad-9daf-f54a92f0e863

Device Description

AN1004.99 EOGas 4 Sterilization Bag, 17/roll

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: Yes
• 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
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13740	Ethylene oxide sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060485030416	GS1
Unit of Use	05060485030508	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150646	000