| Primary Device ID | 00812345029611 |
| NIH Device Record Key | 87cf4ec1-5772-4330-bf90-651250ded5b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q-Tel RMS |
| Version Model Number | QTELS-P-AA |
| Company DUNS | 062046149 |
| Company Name | MORTARA INSTRUMENT, INC. |
| 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 | false |
| 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 | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345029611 [Primary] |
| DSI | Detector And Alarm, Arrhythmia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2016-09-24 |
| 00812345029895 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029888 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029871 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029642 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029635 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029628 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029611 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029604 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029598 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029581 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029574 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029567 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029550 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029543 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029536 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029529 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029512 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029505 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029499 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00812345029482 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00817655021454 | Cardiac and pulmonary rehabilitation data acquisition and editing system |
| 00817655021447 | Software accessory cleared with Q-Tel RMS |
| 00817655021430 | Software accessory cleared with Q-Tel RMS |
| 00817655020105 | Software accessory cleared with Q-Tel RMS |