Fisher and Paykel Healthcare MR340S

GUDID 09420012401601

CHAMBER INFANT ITA / SPA/ POR

FISHER & PAYKEL HEALTHCARE LIMITED

Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable Inspiratory line humidification chamber, reusable
Primary Device ID09420012401601
NIH Device Record Key9b0a3d9b-5140-4516-a3df-92d5704b089e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher and Paykel Healthcare
Version Model NumberMR340S
Catalog NumberMR340S
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
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 Identifiers

Device Issuing AgencyDevice ID
GS109420012401601 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-10
Device Publish Date2022-08-02

On-Brand Devices [Fisher and Paykel Healthcare]

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09420012469694Optiflow+ Nasal Cannula Large myAIRVO 2-pack
09420012469670Optiflow+ Nasal Cannula Medium myAIRVO 2-Pack
09420012469656Optiflow+ Nasal Cannula Small myAIRVO 2-Pack
09420012466716Humidifier MR850 220V EN / KO KC
09420012463838AirSpiral Tube and Chamber Kit myAIRVO
09420012449009Optiflow Junior 2 Ventilator Transition Kit L
09420012448989Optiflow Junior 2 Ventilator Transition Kit M
09420012448958Optiflow Junior 2 Ventilator Transition Kit S
09420012448941Optiflow Junior 2 Ventilator Transition Kit XS
09420012448927Optiflow Junior 2 Blender Transition Kit XL
09420012448903Optiflow Junior 2 Blender Transition Kit L
09420012448880Optiflow Junior 2 Blender Transition Kit M
09420012448866Optiflow Junior 2 Blender Transition Kit S
09420012448828Optiflow Junior 2 Ventilator Transition Kit XL
09420012435989Optiflow Junior 2 Nasal cannula XL
09420012435965Optiflow Junior Nasal cannula L
09420012435941Optiflow Junior 2 Nasal cannula M
09420012435927Optiflow Junior 2 Nasal cannula S
09420012435422Optiflow 3S Nasal Cannula - Large
09420012435408Optiflow 3S Nasal Cannula - Small
09420012426369Optiflow Junior Adaptor Kit
09420012426352Optiflow Junior Oxygen Tubing
09420012424129Infant Nasal Mask Extra Large BCPAP
09420012424112Infant Nasal Mask Large BCPAP
09420012432681Infant Nasal Mask Medium BCPAP
09420012424105Infant Nasal Mask Small BCPAP
09420012414861Nasal Prong BC6570
09420012413109Nasal Prong BC6070
09420012413093Nasal Prong BC6060
09420012413086Nasal Prong BC5560
09420012413079Nasal Prong BC5550
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09420012425263Optiflow Junior Pediatric Nasal Cannula
09420012425256Optiflow Junior Infant Nasal Cannula
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09420012422798Optiflow Nasal Cannula MR850 Medium
09420012422781Optiflow Nasal Cannula MR850 Small
09420012429179FlexiFit 406 Petite Nasal Mask for CPAP or Bi-level ventilation
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09420012429148Humidification Chamber HC150
09420012413345HUMIDIFIER & STARTER KIT
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09420012411815HUMIDIFIER MR810 230V EN / FR / SP
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