ActivePure Medical Guardian

GUDID 00860006810108

Medical Ultraviolet Air Purifier

ACTIVEPURE MEDICAL LLC

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• Primary Device ID: 00860006810108
• NIH Device Record Key: b0ee7e50-f3f5-4dbb-adf2-537075a90b53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivePure Medical Guardian
• Version Model Number: F170A
• Company DUNS: 118037497
• Company Name: ACTIVEPURE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com
• Phone: 800-572-6241
• Email: medical@activepure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006810108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201220

FDA Product Code

• FRA: Purifier, Air, Ultraviolet, Medical

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: 2021-05-20
• Device Publish Date: 2021-05-12