Aerovent Plus®

GUDID 50604351858508

MONAGHAN MEDICAL CORPORATION

Medicine chamber spacer, reusable Medicine chamber spacer, reusable

• Primary Device ID: 50604351858508
• NIH Device Record Key: 830443d1-f149-4617-a6bc-691fbcba9c53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerovent Plus®
• Version Model Number: CHC, cs/50
• Company DUNS: 056332380
• Company Name: MONAGHAN MEDICAL CORPORATION
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 518-561-7330
• Email: customerservice@monaghanmed.com
• Phone: 518-561-7330
• Email: customerservice@monaghanmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00604351858503 [Primary]
GS1	50604351858508 [Package]; Contains: 00604351858503; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110273

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Aerovent Plus®]

• 50604351858508: CHC, cs/50
• 50604351858102: CHC, cs/10