Aerochamber Plus® Z STAT®

GUDID 50604351807100

MONAGHAN MEDICAL CORPORATION

Medicine chamber spacer, reusable

• Primary Device ID: 50604351807100
• NIH Device Record Key: cc4763cf-0a14-47c4-9c18-7d1e4aa4be77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerochamber Plus® Z STAT®
• Version Model Number: aVHC, Large Mask, cs/10
• 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: 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: 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	00604351807105 [Primary]
GS1	50604351807100 [Package]; Contains: 00604351807105; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052332

FDA Product Code

• NVP: Holding Chambers, 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: 2016-09-19

On-Brand Devices [Aerochamber Plus® Z STAT®]

• 50604351887102: aVHC, Small Mask, cs/10
• 50604351807100: aVHC, Large Mask, cs/10
• 50604351797500: aVHC, Mouthpiece, cs/50
• 50604351797104: aVHC, Mouthpiece, cs/10
• 50604351787105: aVHC, Medium Mask, cs/10