AEROCHAMBER* MV Holding Chamber 825110050

GUDID 00762860000827

AEROCHAMBER* MV Holding Chamber

Trudell Medical International

Atomizer, ventilatory

• Primary Device ID: 00762860000827
• NIH Device Record Key: 8e209644-3f0f-4444-b389-ff6849193c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROCHAMBER* MV Holding Chamber
• Version Model Number: 82591
• Catalog Number: 825110050
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• 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: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00762860000827 [Primary]
GS1	10762860000824 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900557

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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: 2023-12-11
• Device Publish Date: 2023-12-01

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• 10762860055039 - REUSABLE COMFORTSEAL® Silicone Mask Assembly: 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers
• 10762860055046 - REUSABLE COMFORTSEAL® Silicone Mask Assembly: 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Large For use with the family of AeroEclipse® nebulizers
• 00762860000827 - AEROCHAMBER* MV Holding Chamber: 2023-12-11AEROCHAMBER* MV Holding Chamber
• 00762860000827 - AEROCHAMBER* MV Holding Chamber: 2023-12-11 AEROCHAMBER* MV Holding Chamber
• 10762860055572 - MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing: 2021-06-29 MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing
• 10762860055534 - AeroEclipse® ONE Breath Actuated Nebulizer Disposable: 2020-08-11 AeroEclipse® ONE Breath Actuated Nebulizer Disposable
• 10762860105024 - AEROBIKA OPEP Manometer: 2020-04-30 AEROBIKA OPEP Manometer