EOGas 4 Refill Kit AN1004.01

GUDID 05060485030454

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

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer

• Primary Device ID: 05060485030454
• NIH Device Record Key: ca35f328-7b3f-486f-9a59-f8d7fb71fc18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EOGas 4 Refill Kit
• Version Model Number: AN1004.01
• Catalog Number: AN1004.01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030454 [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 Refill Kit]

• 05060485030454: AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips,
• 05060485030447: AN1004.16 EOGas 4 Refill Kit, IATA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips