| Primary Device ID | B0361038141 |
| NIH Device Record Key | f2dd9ce3-e15e-416e-abcc-e923861e334b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartMonitor 2PSL Hospital Alarm w/o Modem |
| Version Model Number | 1038141 |
| Catalog Number | 1038141 |
| Company DUNS | 012721295 |
| Company Name | CIRCADIANCE, LLC |
| 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 | false |
| 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 |
| Handling Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC |
| Handling Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC |