AEROTRACH PLUS Anti-Static Valved Holding Chamber

GUDID 00762860015050

AEROTRACH PLUS Anti-Static Valved Holding Chamber

Trudell Medical International

Medicine chamber spacer, reusable

• Primary Device ID: 00762860015050
• NIH Device Record Key: 46fea44d-976d-4ad0-96e9-40c18956ad48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROTRACH PLUS Anti-Static Valved Holding Chamber
• Version Model Number: 101505
• 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	00762860015050 [Primary]
GS1	10762860015057 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	62860101505022 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001137

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: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [AEROTRACH PLUS Anti-Static Valved Holding Chamber]

• 62860101505022: AEROTRACH PLUS Anti-Static Valved Holding Chamber
• 00762860015050: AEROTRACH PLUS Anti-Static Valved Holding Chamber