Primary Device ID | 09420012469694 |
NIH Device Record Key | b6627ec3-28ad-4d14-acba-0ba7e71cb803 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fisher and Paykel Healthcare |
Version Model Number | MYOPT9LARGE |
Catalog Number | MYOPT9LARGE |
Company DUNS | 590153276 |
Company Name | FISHER & PAYKEL HEALTHCARE LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com | |
Phone | 1800 446 3908 |
Customer.CareUSA@fphcare.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09420012469694 [Package] Contains: 09420012469700 Package: PACK [10 Units] In Commercial Distribution |
GS1 | 09420012469700 [Primary] |
BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-10 |
Device Publish Date | 2022-08-02 |
09420012470249 | AirSpiral Tube myAIRVO |
09420012470133 | Optiflow+ Mask Interface myAIRVO 2-pack |
09420012470119 | Optiflow+ Tracheostomy Interface myAIRVO 2-pack |
09420012469694 | Optiflow+ Nasal Cannula Large myAIRVO 2-pack |
09420012469670 | Optiflow+ Nasal Cannula Medium myAIRVO 2-Pack |
09420012469656 | Optiflow+ Nasal Cannula Small myAIRVO 2-Pack |
09420012466716 | Humidifier MR850 220V EN / KO KC |
09420012463838 | AirSpiral Tube and Chamber Kit myAIRVO |
09420012449009 | Optiflow Junior 2 Ventilator Transition Kit L |
09420012448989 | Optiflow Junior 2 Ventilator Transition Kit M |
09420012448958 | Optiflow Junior 2 Ventilator Transition Kit S |
09420012448941 | Optiflow Junior 2 Ventilator Transition Kit XS |
09420012448927 | Optiflow Junior 2 Blender Transition Kit XL |
09420012448903 | Optiflow Junior 2 Blender Transition Kit L |
09420012448880 | Optiflow Junior 2 Blender Transition Kit M |
09420012448866 | Optiflow Junior 2 Blender Transition Kit S |
09420012448828 | Optiflow Junior 2 Ventilator Transition Kit XL |
09420012435989 | Optiflow Junior 2 Nasal cannula XL |
09420012435965 | Optiflow Junior Nasal cannula L |
09420012435941 | Optiflow Junior 2 Nasal cannula M |
09420012435927 | Optiflow Junior 2 Nasal cannula S |
09420012435422 | Optiflow 3S Nasal Cannula - Large |
09420012435408 | Optiflow 3S Nasal Cannula - Small |
09420012426369 | Optiflow Junior Adaptor Kit |
09420012426352 | Optiflow Junior Oxygen Tubing |
09420012424129 | Infant Nasal Mask Extra Large BCPAP |
09420012424112 | Infant Nasal Mask Large BCPAP |
09420012432681 | Infant Nasal Mask Medium BCPAP |
09420012424105 | Infant Nasal Mask Small BCPAP |
09420012414861 | Nasal Prong BC6570 |
09420012413109 | Nasal Prong BC6070 |
09420012413093 | Nasal Prong BC6060 |
09420012413086 | Nasal Prong BC5560 |
09420012413079 | Nasal Prong BC5550 |
09420012432612 | Nasal Prong BC5050 |
09420012413055 | Nasal Prong BC5040 |
09420012425263 | Optiflow Junior Pediatric Nasal Cannula |
09420012425256 | Optiflow Junior Infant Nasal Cannula |
09420012425249 | Optiflow Junior Neonatal Nasal Cannula |
09420012425232 | Optiflow Junior Premature Nasal Cannula |
09420012422804 | Optiflow Nasal Cannula MR850 Large |
09420012422798 | Optiflow Nasal Cannula MR850 Medium |
09420012422781 | Optiflow Nasal Cannula MR850 Small |
09420012429179 | FlexiFit 406 Petite Nasal Mask for CPAP or Bi-level ventilation |
09420012416797 | HUMIDIFIER HC550 230V F/D/G EU |
09420012429148 | Humidification Chamber HC150 |
09420012413345 | HUMIDIFIER & STARTER KIT |
09420012411884 | HUMIDIFIER MR810 230V RUS / POL |
09420012411815 | HUMIDIFIER MR810 230V EN / FR / SP |
09420012407238 | Humidifier MR850 230V DE / FR / IT EU |