AeroChamber Plus® Flow-Vu®

GUDID 00604351003910

MONAGHAN MEDICAL CORPORATION

Medicine chamber spacer, reusable

• Primary Device ID: 00604351003910
• NIH Device Record Key: 12c9147f-31f3-4db2-bb8f-9a0cba9a9deb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroChamber Plus® Flow-Vu®
• Version Model Number: aVHC, Medium Mask, Allergan, Single
• 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	00604351003910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112010

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: 2016-09-30

On-Brand Devices [AeroChamber Plus® Flow-Vu®]

• 50604351888109: aVHC, Small Mask, cs/10
• 00604351888012: aVHC, Small Mask, NFR, Single
• 50604351808107: aVHC, Large Mask, cs/10
• 00604351808010: aVHC, Large Mask, NFR, Single
• 50604351798507: aVHC, Mouthpiece, cs/50
• 50604351798101: aVHC, Mouthpiece, cs/10
• 00604351798014: aVHC, Mouthpiece, NFR, Single
• 50604351788102: aVHC, Medium Mask, cs/10
• 00604351788015: aVHC, Medium Mask, NFR, Single
• 00604351004832: aVHC, Large Mask Demo, Allergan, Single
• 00604351004825: aVHC, Small Mask Demo, Allergan, Single
• 00604351004801: aVHC, Medium Mask Demo, Allergan, Single
• 00604351004788: aVHC, Mouthpiece Demo, Allergan, Single
• 00604351003927: aVHC, Large Mask, Allergan, Single
• 00604351003910: aVHC, Medium Mask, Allergan, Single
• 00604351003903: aVHC, Small Mask, Allergan, Single
• 00604351003897: aVHC, Mouthpiece, Allergan, Single
• 50604351889106: aVHC, Intermediate Mask, cs/10
• 50604351503125: AC Plus, Flow-Vu aVHC, Large Mask, Retail - 50312
• 50604351502128: AC Plus, Flow-Vu aVHC, Medium Mask, Retail - 50212
• 50604351501121: AC Plus, Flow-Vu aVHC, Small Mask, Retail - 50112
• 00604351500129: AC+FV aVHC Mouthpiece Retail - 50012
• 50604351504122: AC Plus, Flow-Vu aVHC, Intermediate Mask, Retail - 50412