AEROCHAMBER mini Holding Chamber

GUDID 00762860875012

AEROCHAMBER mini Holding Chamber

Trudell Medical International

Metered dose inhaler

• Primary Device ID: 00762860875012
• NIH Device Record Key: 195dbe20-d735-4a5c-81c8-b0211f02e434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROCHAMBER mini Holding Chamber
• Version Model Number: 87501
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00762860875012 [Primary]
GS1	10762860875019 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	62860875010029 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090065

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: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [AEROCHAMBER mini Holding Chamber]

• 62860875010029: AEROCHAMBER mini Holding Chamber
• 00762860875012: AEROCHAMBER mini Holding Chamber