| Primary Device ID | 09420012406316 |
| NIH Device Record Key | 21f821b2-c6b4-47ac-b794-9c8e312321ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fisher and Paykel Healthcare |
| Version Model Number | HC500JHU |
| Catalog Number | HC500JHU |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 09420012406316 [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 |