Innova Full Face Vented Mask, Large

GUDID 00814747021040

Full face vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00814747021040
• NIH Device Record Key: 4d5f89c7-467c-4407-8592-c320259c6c5a
• Commercial Distribution Discontinuation: 2019-04-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Innova Full Face Vented Mask, Large
• Version Model Number: 50854
• 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
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx
• Phone: 1-800-742-3646
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747021040 [Primary]
GS1	00814747021866 [Primary]

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: 3
• Public Version Date: 2019-04-24
• Device Publish Date: 2016-02-01

Devices Manufactured by SLEEPNET, CORP.

• 00814747024614 - MiniMe Pediatric Mask with Headgear, Size Small: 2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
• 00814747024621 - MiniMe Pediatric Mask with Headgear, Size Medium: 2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
• 00814747024638 - MiniMe Pediatric Mask with Headgear, Size Large: 2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
• 00814747024645 - MiniMe Pediatric Ventilation Mask with Headgear, Size Small: 2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
• 00814747024652 - MiniMe Pediatric Ventilation Mask with Headgear, Size Medium: 2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
• 00814747024669 - MiniMe Pediatric Ventilation Mask with Headgear, Size Large: 2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
• 10814747024598 - Veraseal 2 Full Face Vented Mask, Extra Large: 2025-02-19 Disposable full face vented mask for use in positive pressure ventilation.
• 10814747024413 - Novaplus Full Face Non Vented Mask, Large: 2025-02-13 Disposable full face non vented mask for use in positive pressure ventilation.