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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012448361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190713

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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

• 09420012469533 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Small
• 09420012469557 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Large
• 09420012469571 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Medium
• 09420012475312 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Small (2-pack)
• 09420012474735 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Medium (2-pack)
• 09420012475336 - Fisher & Paykel Healthcare: 2024-04-05 Nasal Cannula - Large (2-pack)
• 09420012479631 - Fisher & Paykel Healthcare: 2024-04-05 Fisher & Paykel Healthcare Device Manager
• 09420012461049 - Fisher & Paykel Healthcare: 2023-11-13 Bi-Level / CPAP Single Limb Circuit Kit