EOGas 4 Refill Kit AN1004.00

GUDID 05060485030164

AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 Humidichips, 26 EOGas 4 sterilization bags

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer

• Primary Device ID: 05060485030164
• NIH Device Record Key: b0811fb5-9ea5-4a39-8e6c-3b99be5ccbba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EOGas 4 Refill Kit
• Version Model Number: AN1004.00
• Catalog Number: AN1004.00
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-523-1276
• Email: customerservice@anpro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150646

FDA Product Code

• FLF: Sterilizer, Ethylene-Oxide Gas

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-02
• Device Publish Date: 2018-09-01

Devices Manufactured by ANDERSEN STERILIZERS INC.

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• 05060485030744 - AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V: 2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle, stainless steel cabinet, 230V
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• 05060485030614 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V: 2020-08-24 AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V
• 05060485030621 - Anprolene AN75 Ethylene Oxide Sterilizer, 115V: 2020-08-24 Anprolene AN75 Ethylene Oxide Sterilizer, 115V