Fisher & Paykel Healthcare 900MR749

GUDID 09420012403056

Circuit kit inspiratory/expiratory heated 1.25m (50in) paediatric

FISHER & PAYKEL HEALTHCARE LIMITED

Ventilator breathing circuit, reusable
Primary Device ID09420012403056
NIH Device Record Key50ae7b89-fdee-4eb6-9c3a-14c9168835bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher & Paykel Healthcare
Version Model Number900MR749
Catalog Number900MR749
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
GS109420012403056 [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

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