Veraseal 3 Full Face Vented Mask, Extra Large

GUDID 10814747021481

Disposable full face vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use

• Primary Device ID: 10814747021481
• NIH Device Record Key: 0ce3c0ab-e859-4771-981c-5edd65b39664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veraseal 3 Full Face Vented Mask, Extra Large
• Version Model Number: 50846
• Company DUNS: 785635186
• Company Name: SLEEPNET, CORP.
• 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: true
• 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: 1-800-742-3646
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747021484 [Primary]
GS1	10814747021481 [Package]; Contains: 00814747021484; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-13
• Device Publish Date: 2019-05-03

Devices Manufactured by SLEEPNET, CORP.

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• 00814747023693 - Mojo Full Face Mask, Medium with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023709 - Mojo Full Face Mask, Large with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023716 - Mojo Full Face Mask, Extra Large with Headgear: 2024-04-11 Full face vented mask for use in positive pressure ventilation.
• 00814747023723 - Mojo Non Vented Full Face Mask, Small with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023730 - Mojo Non Vented Full Face Mask, Medium with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023747 - Mojo Non Vented Full Face Mask, Large with Headgear: 2024-04-11 Full face non vented mask for use in positive pressure ventilation.
• 00814747023761 - Mojo 2 Full Face Vented Mask, Small: 2024-04-11 Full face vented mask for use in positive pressure ventilation.