Fisher & Paykel Healthcare 900MR568

GUDID 09420012401168

Airway temperature probe 90°, 1.45m

FISHER & PAYKEL HEALTHCARE LIMITED

Breathing circuit multi-parameter sensor
Primary Device ID09420012401168
NIH Device Record Keya5e713a0-54cf-4a83-8898-f8a287a24127
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher & Paykel Healthcare
Version Model Number900MR568
Catalog Number900MR568
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
GS109420012401168 [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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09420012448460F&P Vitera Full Face Mask - Large A For Bi-level ventilation
09420012449191F&P Vitera Full Face Mask - Medium A For Bi-level ventilation
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09420012424372Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber
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09420012403469Adult respiratory circuit dual heated
09420012414427Adult respiratory circuit single heated
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09420012403582Adult breathing circuit inspiratory heated with MR290 autofeed chamber
09420012417244Adult ventilator circuit dual heated with MR290 autofeed chamber
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09420012424365Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber
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09420012403148Neonatal reusable low flow circuit with Watertrap
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