FISHER & PAYKEL HEALTHCARE EVO1MSL

GUDID 09420012460080

F&P Evora Nasal Mask - Medium SL For Positive Airway Pressure Therapy

FISHER & PAYKEL HEALTHCARE LIMITED

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable
Primary Device ID09420012460080
NIH Device Record Key46fc70f6-cf69-4097-85a3-f593909e9d27
Commercial Distribution StatusIn Commercial Distribution
Brand NameFISHER & PAYKEL HEALTHCARE
Version Model NumberEVO1MSL
Catalog NumberEVO1MSL
Company DUNS590153276
Company NameFISHER & PAYKEL HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com
Phone1800 446 3908
EmailCustomer.CareUSA@fphcare.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109420012456403 [Primary]
GS109420012460080 [Package]
Contains: 09420012456403
Package: PACK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


[09420012460080]

Dry Heat Sterilization;Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-03
Device Publish Date2021-07-26

On-Brand Devices [FISHER & PAYKEL HEALTHCARE]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.