Aerogen® Go

GUDID 04719873130207

The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.

HCMED INNOVATIONS CO., LTD.

Medicine chamber spacer, reusable

• Primary Device ID: 04719873130207
• NIH Device Record Key: 839f9572-b444-47b6-ad8b-abe4c18f43cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerogen® Go
• Version Model Number: 00USA86C0005
• 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: true
• 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	04719873130207 [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