REUSABLE COMFORTSEAL® Silicone Mask Assembly

GUDID 10762860055039

REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers

Trudell Medical International

Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use

• Primary Device ID: 10762860055039
• NIH Device Record Key: 032b914b-309f-4ea0-956f-be26d5bc13da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUSABLE COMFORTSEAL® Silicone Mask Assembly
• Version Model Number: 105503
• 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
• 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	00762860055032 [Primary]
GS1	10762860055039 [Package]; Contains: 00762860055032; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• BYG: Mask, Oxygen

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: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [REUSABLE COMFORTSEAL® Silicone Mask Assembly]

• 10762860055046: REUSABLE COMFORTSEAL® Silicone Mask Assembly – Large For use with the family of AeroEclipse®
• 10762860055039: REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse®
• 10762860055022: REUSABLE COMFORTSEAL® Silicone Mask Assembly – Medium For use with the family of AeroEclipse�