Aerogen® Go

GUDID 04719873130214

The Aerogen Go Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir. The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor. This AC adaptor is in the sales package.

HCMED INNOVATIONS CO., LTD.

Noninvasive device battery charger

• Primary Device ID: 04719873130214
• NIH Device Record Key: d282142e-c82c-46f0-b889-dd815c26fe1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerogen® Go
• Version Model Number: 04EE12000012
• Company DUNS: 656242259
• Company Name: HCMED INNOVATIONS CO., LTD.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com
• Phone: 18664237643
• Email: USACustomerSupport@aerogen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873130214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202171

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2026-02-05
• Device Publish Date: 2026-01-28

On-Brand Devices [Aerogen® Go ]

• 04719873131228: The Aerogen®Go Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpos
• 04719873130351: The Aerogen Go Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and ma
• 04719873130214: The Aerogen Go Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and ma
• 04719873130207: The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will