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 ID09420012448361
NIH Device Record Keyd6ee2c51-db9d-4a19-9a24-8ab2d15f17ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameFISHER & PAYKERL HEALTHCARE
Version Model NumberVIT1LLA
Catalog NumberVIT1LLA
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 Datetrue
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

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109420012448361 [Primary]
GS109420012449399 [Package]
Package: PACK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-11
Device Publish Date2019-11-02

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