AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V AN4000.60

GUDID 05060485030706

EOGas 4 Sterilizer with 3 & 6 hour cycle options, 115V

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer Ethylene oxide sterilizer

• Primary Device ID: 05060485030706
• NIH Device Record Key: 32b942ab-eb55-436e-a455-d71ca36e9956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V
• Version Model Number: AN4000.60
• Catalog Number: AN4000.60
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192978

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: 2023-09-08
• Device Publish Date: 2023-08-31

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