EOGas 4 Ethylene Oxide Gas Sterilizer AN4000.01

GUDID 05060485030393

AN4000.01 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer

• Primary Device ID: 05060485030393
• NIH Device Record Key: 565fafc3-69fe-4099-91c3-e4e6f7bf8d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EOGas 4 Ethylene Oxide Gas Sterilizer
• Version Model Number: AN4000.01
• Catalog Number: AN4000.01
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	05060485030393 [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

On-Brand Devices [EOGas 4 Ethylene Oxide Gas Sterilizer]

• 05060485030409: AN4000.11 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V
• 05060485030393: AN4000.01 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V