AN1071 Humidichip AN1071.16

GUDID 05060485030430

AN1071.16 Humidichip, 16 units

ANDERSEN STERILIZERS INC.

Ethylene oxide sterilizer

• Primary Device ID: 05060485030430
• NIH Device Record Key: f95f41e4-3f3a-4f9c-a3be-a58fe7008893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN1071 Humidichip
• Version Model Number: AN1071.16
• Catalog Number: AN1071.16
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 16
• 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: 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	05060485030430 [Primary]
GS1	05060485030492 [Unit of Use]

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 [AN1071 Humidichip]

• 05060485030430: AN1071.16 Humidichip, 16 units
• 05060485030331: AN1071.00 Humidichip, 25 units