F&P Vitera VIT1SMLA

GUDID 09420012461636

F&P Vitera Full Face PAP Therapy Mask - Small/Medium/Large A

FISHER & PAYKEL HEALTHCARE LIMITED

CPAP/BPAP face mask, reusable

• Primary Device ID: 09420012461636
• NIH Device Record Key: cfff152a-452f-49cf-bf29-7c1a2c6511bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F&P Vitera
• Version Model Number: VIT1SMLA
• Catalog Number: VIT1SMLA
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012461629 [Primary]
GS1	09420012461636 [Package]; Contains: 09420012461629; Package: PACK [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-04
• Device Publish Date: 2026-01-27

Devices Manufactured by FISHER & PAYKEL HEALTHCARE LIMITED

• 09420012429803 - FISHER & PAYKEL HEALTHCARE: 2026-04-01 ENTRAINER AIR 20BX
• 09420012405913 - Fisher & Paykel Healthcare: 2026-03-31 Waterbag Pole 1.25 m
• 09420012429810 - FISHER & PAYKEL HEALTHCARE: 2026-03-31 Air entrainer
• 09420012429940 - FISHER & PAYKEL HEALTHCARE: 2026-03-30 S/USE RESUS KIT W 42MM MSK(10)Single use T-Piece-Classic with mask 42mm
• 09420012429957 - FISHER & PAYKEL HEALTHCARE: 2026-03-30 Single use T-Piece-Classic with mask 50mm
• 09420012429964 - FISHER & PAYKEL HEALTHCARE: 2026-03-30 Single use T-Piece-Classic with mask 60mm
• 09420012416582 - FISHER & PAYKEL HEALTHCARE: 2026-03-30 Single use T-Piece Circuit- Humidified
• 09420012430021 - FISHER & PAYKEL HEALTHCARE: 2026-03-30 Ergonomic T-Piece Circuit with Mask 42mm