Fisher & Paykel Healthcare 900MR563

GUDID 09420012401144

Airway temperature probe - 90°, 1.10m

FISHER & PAYKEL HEALTHCARE LIMITED

Breathing circuit multi-parameter sensor
Primary Device ID09420012401144
NIH Device Record Keyac24a08d-81ee-4867-b037-bd0b664d6c8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher & Paykel Healthcare
Version Model Number900MR563
Catalog Number900MR563
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109420012401144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-08

On-Brand Devices [Fisher & Paykel Healthcare]

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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
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09420012418197Infant continuous flow circuit (> 4 L/min) single heated with MR290 autofeed chamber
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09420012424372Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber
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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
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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
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09420012425409Adult single limb circuit inspiratory heated for use with MR810 only
09420012403148Neonatal reusable low flow circuit with Watertrap
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