FISHER & PAYKERL HEALTHCARE VIT1LLA

GUDID 09420012448361

F&P Vitera Full Face Mask - Large/ Large A For Bi-level ventilation

FISHER & PAYKEL HEALTHCARE LIMITED

CPAP/BPAP face mask, reusable

• Primary Device ID: 09420012448361
• NIH Device Record Key: d6ee2c51-db9d-4a19-9a24-8ab2d15f17ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FISHER & PAYKERL HEALTHCARE
• Version Model Number: VIT1LLA
• Catalog Number: VIT1LLA
• Company DUNS: 590153276
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012448361 [Primary]
GS1	09420012449399 [Package]; Package: PACK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190713

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)
• BZD: Ventilator, Non-Continuous (Respirator)

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: 2019-11-11
• Device Publish Date: 2019-11-02

Devices Manufactured by FISHER & PAYKEL HEALTHCARE LIMITED

• 09420012473813 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Small A
• 09420012473820 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Medium A
• 09420012473837 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Large A
• 09420012473844 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Fit Pack S/M/L A
• 09420012473967 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Small SL A
• 09420012473974 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Medium SL A
• 09420012473981 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Large SL A
• 09420012473998 - Nova: 2025-09-23 F&P Nova Nasal (Nasal PAP Therapy Mask) - Fit Pack S/M/L SL A