Medical Guardian

GUDID 00860006514808

Aerus LLC

High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile High-efficiency filter air cleaner, mobile

• Primary Device ID: 00860006514808
• NIH Device Record Key: 4fae0ee4-f102-4d9d-a2d9-7a6764e4595d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Guardian
• Version Model Number: F170A
• Company DUNS: 098188469
• Company Name: Aerus 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00860006514808 [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: 2021-04-09
• Device Publish Date: 2021-04-01