EOGas 4 Refill Kit

Basic Information

• Brand Name: EOGas 4 Refill Kit
• Primary DI: 05060485030454
• Version / Model: AN1004.01
• Catalog Number: AN1004.01
• Company Name: ANDERSEN STERILIZERS INC.
• Labeler DUNS: 931853006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: ca35f328-7b3f-486f-9a59-f8d7fb71fc18

Device Description

AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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	05060485030454	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150646	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius