Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V AN75.65

GUDID 05060485030614

AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V

ANDERSEN STERILIZERS INC.

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• Primary Device ID: 05060485030614
• NIH Device Record Key: fd0f36a0-d1aa-4556-97d4-0fdfd6bbb64e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V
• Version Model Number: AN75.65
• Catalog Number: AN75.65
• 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: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170432

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: 2020-08-24
• Device Publish Date: 2020-08-14

On-Brand Devices [Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V]

• 05060485030638: Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V
• 05060485030614: AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V