Varifit NIV Non Vented Mask, Extra Large Adult

GUDID 00814747024584

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

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use

• Primary Device ID: 00814747024584
• NIH Device Record Key: 1e50dc15-c280-48c0-a047-599025c9bdbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varifit NIV Non Vented Mask, Extra Large Adult
• Version Model Number: 22790
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814747021293 [Previous]
GS1	00814747024577 [Primary]
GS1	00814747024584 [Package]; Contains: 00814747024577; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2025-02-12
• Device Publish Date: 2025-02-04

On-Brand Devices [Varifit NIV Non Vented Mask, Extra Large Adult]

• 00814747021323: Disposable full face non vented mask for use in positive pressure ventilation.
• 00814747024584: Disposable full face non vented mask for use in positive pressure ventilation.