| Primary Device ID | 00619498629466 |
| NIH Device Record Key | b06799c6-2ff2-4c2e-868d-6b1d2bb438c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AirFit P10 |
| Version Model Number | 62946 |
| Company DUNS | 751149311 |
| Company Name | RESMED PTY LTD |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619498629466 [Primary] |
| 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 | 2022-06-14 |
| Device Publish Date | 2022-06-06 |
| 00619498629800 | CPL AirFit P10 Mask Sys - Amer |
| 00619498629480 | CPL AirFit P10 Frame Sys Large |
| 00619498629473 | CPL AirFit P10 Frame Sys Medium |
| 00619498629466 | CPL AirFit P10 Frame Sys Small |