Fisher and Paykel Healthcare OPT312

GUDID 09420012425232

Optiflow Junior Premature Nasal Cannula

FISHER & PAYKEL HEALTHCARE LIMITED

Nasal oxygen cannula, basic
Primary Device ID09420012425232
NIH Device Record Key053d2b39-5a62-41ea-89dc-b38781b4a816
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher and Paykel Healthcare
Version Model NumberOPT312
Catalog NumberOPT312
Company DUNS590153276
Company NameFISHER & PAYKEL HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS109420012425232 [Package]
Contains: 09420012432278
Package: PACK [20 Units]
In Commercial Distribution
GS109420012432278 [Primary]

FDA Product Code

CATCannula, Nasal, Oxygen

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

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09420012466716Humidifier MR850 220V EN / KO KC
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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
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