Fisher & Paykel Healthcare EVF1MMA

GUDID 09420012461803

F&P Evora Full Face PAP Therapy Mask - S-M/S-M A

FISHER & PAYKEL HEALTHCARE LIMITED

CPAP/BPAP face mask, reusable

• Primary Device ID: 09420012461803
• NIH Device Record Key: 410a1f76-0f2e-454b-be01-04b4e546b984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fisher & Paykel Healthcare
• Version Model Number: EVF1MMA
• Catalog Number: EVF1MMA
• 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
• 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
• 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
• 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
• 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
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012461797 [Primary]
GS1	09420012461803 [Package]; Contains: 09420012461797; Package: PACK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212371

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: 2022-04-05
• Device Publish Date: 2022-03-28

On-Brand Devices [Fisher & Paykel Healthcare]

• 09420012433787: myAIRVO 2 Heated Breathing Tube
• 09420012433770: myAIRVO 2 Heated Breathing Tube
• 09420012448019: Infosmart Web
• 09420012448415: Sleepstyle Water Chamber
• 09420012448347: Sleepstyle Thermosmart Breathing Tube
• 09420012448354: Slepstyle Standard Breathing Tube with Elbow
• 09420012433763: myAIRVO 2 Heated Breathing Tube and Chamber Kit
• 09420012417480: Respiratory Humidifier 230V GE/FR/CH
• 09420012407252: Respiratory Humidifier MR850 230V NO/SW/FI
• 09420012427854: F&P InfoUSB
• 09420012421524: SMARTSTICK-5 PACK HC254
• 09420012449382: F&P Vitera Full Face Mask - Medium/ Medium A For Bi-level ventilation
• 09420012449481: F&P Vitera Full Face Mask - Large SL For Bi-level ventilation
• 09420012448460: F&P Vitera Full Face Mask - Large A For Bi-level ventilation
• 09420012449191: F&P Vitera Full Face Mask - Medium A For Bi-level ventilation
• 09420012449498: F&P Vitera Full Face Mask - Medium/ Large SL For Bi-level ventilation
• 09420012403551: Infant ventilator circuit (0.3 to 4 L/min) single heated
• 09420012411501: Infant ventilator circuit (> 4 L/min) single heated
• 09420012418197: Infant continuous flow circuit (> 4 L/min) single heated with MR290 autofeed chamber
• 09420012412065: Infant continuous flow circuit (> 4 L/min) single heated
• 09420012424372: Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber
• 09420012413253: Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber
• 09420012417947: Infant continuous flow circuit (0.3 to 10 L/min) singleheated with MR290 autofeed chamber and pr
• 09420012424136: Optiflow Tubing Kit
• 09420012412966: Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber
• 09420012417268: Adult ventilator circuit Inspiratory heated with MR290 autofeed chamber
• 09420012403506: Adult respiratory circuit single heated
• 09420012403469: Adult respiratory circuit dual heated
• 09420012414427: Adult respiratory circuit single heated
• 09420012403476: Adult respiratory circuit dual heated
• 09420012424716: Adult ventilator circuit dual heated with Evaqua Technology
• 09420012414311: Bi-level/CPAP limb heated with extension and respironics exhalation port
• 09420012417534: Adult oxygen therapy circuit heated, with MR290, RT008 and RT022
• 09420012403490: Heated inspiratory line
• 09420012428837: Dual limb adult circuit kit with Evaqua 2 technology
• 09420012418067: Adult ventilator circuit dual heated with MR290
• 09420012417862: Respironics bi-level/CPAP limb heated with MR290 chamber and extension
• 09420012403582: Adult breathing circuit inspiratory heated with MR290 autofeed chamber
• 09420012417244: Adult ventilator circuit dual heated with MR290 autofeed chamber
• 09420012414571: Adult ventilator circuit dual heated with MR290 and RT019
• 09420012424365: Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber
• 09420012424181: Adult ventilator circuit dual heated with Evaqua Technology
• 09420012427830: Tube and Chamber Kit (Junior)
• 09420012427793: Heated Breathing Tube
• 09420012427816: Tube and Chamber Kit - Airvo2
• 09420012427823: Heated Breathing Tube
• 09420012425409: Adult single limb circuit inspiratory heated for use with MR810 only
• 09420012403148: Neonatal reusable low flow circuit with Watertrap
• 09420012403131: Neonatal reusable bias flow circuit with Watertrap
• 09420012403117: Adult reusable circuit 1.5 m with watertrap