| Primary Device ID | 09420012448361 |
| NIH Device Record Key | d6ee2c51-db9d-4a19-9a24-8ab2d15f17ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FISHER & PAYKERL HEALTHCARE |
| Version Model Number | VIT1LLA |
| Catalog Number | VIT1LLA |
| 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 | 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09420012448361 [Primary] |
| GS1 | 09420012449399 [Package] Package: PACK [10 Units] In Commercial Distribution |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2019-11-02 |
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| 09420012463210 - Fisher & Paykel Healthcare | 2024-09-19 Optiflow Junior 2 Home Nasal Cannula |
| 09420012463135 - Fisher & Paykel Healthcare | 2024-09-19 myAIRVO water bottle |
| 09420012466655 - Fisher & Paykel Healthcare | 2024-09-19 myAirvo 3 Respiratory support device |
| 09420012466679 - Fisher & Paykel Healthcare | 2024-09-19 Airvo 3 NIV Respiratory Support Device |
| 09420012476562 - Fisher & Paykel Healthcare | 2024-09-19 Optiflow Filtered Nasal Interface With Anesthesia Mask Compatibility |
| 09420012476586 - Fisher & Paykel Healthcare | 2024-09-19 Optiflow Filtered Nasal Interface With Anesthesia Mask Compatibility |
| 09420012476609 - Fisher & Paykel Healthcare | 2024-09-19 Optiflow Filtered Nasal Interface With Anesthesia Mask Compatibility |