| Primary Device ID | 09420012417251 |
| NIH Device Record Key | 11ba0445-22dd-4d1d-8836-cab8dc40d840 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fiaher & Paykel Healthcare |
| Version Model Number | RT211 |
| Catalog Number | RT211 |
| 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 | 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 | |
| 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 | 09420012417251 [Package] Contains: 09420012430502 Package: Pack [10 Units] In Commercial Distribution |
| GS1 | 09420012430502 [Primary] |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2016-09-08 |
| 09420012477873 - F&P Airvo 3 | 2026-02-05 Pulse Oximetry Connectoin Converter 1 |
| 09420012461636 - F&P Vitera | 2026-02-04 F&P Vitera Full Face PAP Therapy Mask - Small/Medium/Large A |
| 09420012479112 - F&P OptiPAP Junior | 2026-02-02 OptiPAP Junior Chinstrap 17-24cm |
| 09420012479136 - F&P OptiPAP Junior | 2026-02-02 OptiPAP Junior Chinstrap 23-30cm |
| 09420012479150 - F&P OptiPAP Junior | 2026-02-02 OptiPAP Junior Chinstrap 29-37cm |
| 09420012479174 - F&P OptiPAP Junior | 2026-02-02 OptiPAP Junior Chinstrap 36-45cm |
| 09420012479198 - F&P OptiPAP Junior | 2026-01-28 OptiPAP Junior Bonnet Kit 17-22cm |
| 09420012479211 - F&P OptiPAP Junior | 2026-01-28 OptiPAP Junior Bonnet Kit 20-26cm |